Lydia Soto-Torres - Academia.edu (original) (raw)

Papers by Lydia Soto-Torres

Research paper thumbnail of How a menu of adherence support strategies facilitated high adherence to HIV prevention products among adolescent girls and young women in sub‐Saharan Africa: a mixed methods analysis

Journal of the International AIDS Society

IntroductionEffective use of pre‐exposure prophylaxis (PrEP) has been low among adolescent girls ... more IntroductionEffective use of pre‐exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in sub‐Saharan Africa. The MTN‐034/REACH trial offered AGYW a menu of adherence support strategies and achieved high adherence to both daily oral PrEP and the monthly dapivirine vaginal ring. Understanding how these strategies promoted product use could inform the design of adherence support systems in programmatic settings.MethodsREACH was a randomized crossover trial evaluating the safety of and adherence to the ring and oral PrEP among 247 HIV‐negative AGYW (ages 16–21) in South Africa, Uganda and Zimbabwe from January 2019 to September 2021 (NCT03593655). Adherence support included monthly counselling sessions with drug‐level feedback (DLF) plus optional daily short message service (SMS) reminders, weekly phone or SMS check‐ins, peer support clubs, “peer buddies” and additional counselling. Counsellors documented adherence support choices and counselling conten...

Research paper thumbnail of Efficacy and Action of the Dapivirine Vaginal Ring as Understood by Women Participating in an Open Label Extension Study

Aids and Behavior, Jun 7, 2022

Research paper thumbnail of Adolescent Girls and Young Women’s Experiences with Disclosing Oral PrEP or Dapivirine Vaginal Ring Use: a Multi-Country Qualitative Analysis

AIDS and Behavior

Effective use of oral pre-exposure prophylaxis (PrEP) has been low among adolescent girls and you... more Effective use of oral pre-exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in Eastern and Southern Africa, partly due to stigma and opposition from key influencers. Understanding AGYW’s experiences of disclosure of different PrEP modalities to key influencers may inform strategies to motivate uptake and adherence. We analyzed qualitative in-depth interviews and focus group discussions data from 119 participants in the MTN-034/REACH (Reversing the Epidemic in Africa with Choices in HIV Prevention) study of oral PrEP and the dapivirine vaginal ring (ring) to explore AGYW’s disclosure experiences. We found that AGYW disclosure experiences varied across influencers and product type. The ring was disclosed less often to most influencers, except partners, because it was discreet. Oral PrEP was disclosed more often, because pills were more common and to avoid HIV stigma given that oral PrEP resembled HIV treatment. Ultimately, disclosure typically led ...

Research paper thumbnail of Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial

JAIDS Journal of Acquired Immune Deficiency Syndromes

BACKGROUND Persistent use of HIV prevention methods can be a challenge, particularly for some you... more BACKGROUND Persistent use of HIV prevention methods can be a challenge, particularly for some younger women. The long-acting, discreet, woman-centric dapivirine vaginal ring offers promise as a prevention method with less user burden, which could support continued use. We assessed dapivirine vaginal ring use to understand adherence patterns and identify characteristics influencing patterns. SETTING Participants enrolled in South Africa in the MTN-020/ASPIRE randomized placebo-controlled trial. METHODS We used group-based trajectory modeling to identify clusters of participants with similar longitudinal patterns of adherence in last year of participation and potential predictors of group membership. Women with at least one year of follow-up were included (n=626). RESULTS Five adherence patterns were identified: (1) consistently high, 34%, (2) consistently moderate, 34%, (3) consistently low, 16%, (4) decreasing, 9%, and (5) increasing, 7%.Women <22 years (adjusted odds ratio [AOR] 1.8, 95% Confidence Interval [CI]: 1.0, 3.0), those using an intrauterine device [AOR 3.3, 95% CI: 1.4, 7.8] or oral contraceptives [AOR 3.9, 95% CI: 1.7, 8.9], experiencing menses [AOR 1.8, 95% CI: 1.1, 3.0] and who reported inconsistent condom use [AOR 1.8, 95% CI: 1.0, 3.3] were more likely to be classified as consistently low compared to consistently high. CONCLUSION Most South African women successfully persisted with moderate or high-level of use. Encouraging ring replacement with completion of menses may help to decrease concerns about hygiene and improve persistence. Associations between contraception and persistent low adherence suggest efforts may be needed to ensure contraceptive method choice does not interfere with ring use.

Research paper thumbnail of Pharmacokinetic cross-over study in women comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other anatomic compartments (MTN-001)

Research paper thumbnail of HPTN 069/ACTG A5305: phase II study of maraviroc-containing regimens for HIV PrEP in US women; Postive impact of a randomized controlled trial of the Uthando Lwethu ("Our Love") intervention on rates of couples HIV testing in rural South Africa

Research paper thumbnail of Chapter 11 Housing and Health: Exploring the Complex Intersections Between Housing Environments and Health Behaviors Among Women Living in Poverty

Poverty in the United States, 2016

Location, quality, and reliability of housing are associated with physical and mental health. Fin... more Location, quality, and reliability of housing are associated with physical and mental health. Financial resources (or lack thereof) and availability of affordable housing may restrict housing choice and mobility. Women, and unmarried women with children in particular, experience greater poverty rates than other groups, and, as a result, are particularly vulnerable to the ill effects of precarious housing conditions. This chapter explores interview and focus group themes as they relate to women’s experiences of their housing environment. The aims of this chapter are to (1) describe the physical attributes of housing where women reside, and the social and built characteristics of the neighborhoods where this housing is situated, and (2) explore how poverty affects housing choice and mobility. Participants felt trapped by marginal living situations resulting from limited housing choice, financial constraints, and transportation needs. Participants believed that their environments affected their physical and emotional well-being and described trade-offs that had immediate and long-term health implications (e.g., exchanging sex for housing, staying in dilapidated housing to keep benefits), and perceived low control over these situations. Women living in poverty require assistance identifying and relocating to safe, affordable housing with adequate transportation access. Programming should be coupled with interventions to increase women’s financial assets and mental health and with reevaluations of policies contributing to poverty and unstable housing.

Research paper thumbnail of Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India

AIDS research and therapy, Jan 20, 2006

The objective of this study was to evaluate the safety of twice daily, intra-vaginal use of 0.5% ... more The objective of this study was to evaluate the safety of twice daily, intra-vaginal use of 0.5% PRO 2000 Gel for fourteen days in HIV un-infected women at lower as well as higher risk for HIV acquisition, in Pune, India. Forty-two eligible volunteers (30 low-risk and 12 high-risk) were given 0.5% PRO 2000 Gel for intra-vaginal application twice daily for 14 consecutive days. Twenty-four participants (57%, 95% CI 41%-72%) experienced at least one adverse event (AE) judged to be possibly related to the product use. There were 17 (40%, 95% CI 26%-57%) mild AEs and 7 (17%, 95% CI 7%-31%) moderate AEs. There were no serious adverse events and no AEs judged probably or definitely related to product use. Genitourinary discomfort was reported by 2/30 (6.67%) participants in the low-risk cohort as compared to 4/12 (33.3%) women in the high-risk cohort (p = 0.03). Intermenstrual bleeding was reported in 2/30 (6.7%, 95% CI 1.0-22.1) women from the low risk cohort and 3/12 (25%, 95% CI 5.5-57....

Research paper thumbnail of Baseline preferences for oral pre-exposure prophylaxis (PrEP) or dapivirine intravaginal ring for HIV prevention among adolescent girls and young women in South Africa, Uganda and Zimbabwe (MTN-034/IPM-045 study)

PLOS ONE

Introduction Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately... more Introduction Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately affected by the HIV epidemic and face an array of challenges using proven behavioral and biomedical prevention methods. To address the urgent need for expanding prevention options, we evaluated the baseline preferences of HIV prevention methods among participants enrolled in the MTN-034/REACH crossover trial along with their stated product preference prior to product initiation. Methods AGYW aged 16–21 years were enrolled at 4 study sites: Cape Town and Johannesburg, South Africa; Kampala, Uganda; and Harare, Zimbabwe and randomly assigned to the sequence of using oral PrEP and the dapivirine ring for 6 months each, followed by a choice period in which they could choose either product (or neither) for an additional six months. Eligible AGYW were HIV-negative, not pregnant and using effective contraception for at least two months prior to enrollment. Descriptive statistics were used to s...

Research paper thumbnail of Sexual Behaviors of US Women at Risk of HIV Acquisition: A Longitudinal Analysis of Findings from HPTN 064

AIDS and behavior, Jan 29, 2015

We describe the sexual behaviors of women at elevated risk of HIV acquisition who reside in areas... more We describe the sexual behaviors of women at elevated risk of HIV acquisition who reside in areas of high HIV prevalence and poverty in the US. Participants in HPTN 064, a prospective HIV incidence study, provided information about individual sexual behaviors and male sexual partners in the past 6 months at baseline, 6- and 12-months. Independent predictors of consistent or increased temporal patterns for three high-risk sexual behaviors were assessed separately: exchange sex, unprotected anal intercourse (UAI) and concurrent partnerships. The baseline prevalence of each behavior was >30 % among the 2,099 participants, 88 % reported partner(s) with >1 HIV risk characteristic and both individual and partner risk characteristics decreased over time. Less than high school education and food insecurity predicted consistent/increased engagement in exchange sex and UAI, and partner's concurrency predicted participant concurrency. Our results demonstrate how interpersonal and soc...

Research paper thumbnail of Correlates of Dapivirine Vaginal Ring Acceptance among Women Participating in an Open Label Extension Trial

Research paper thumbnail of Does the ring work? Perceptions and understandings of the efficacy of a vaginal ring for HIV prevention amongst women participating in the MTN-032/AHA study

HIV Research for Prevention 2021, Jan 26, 2021

Research paper thumbnail of The impact of participant engagement activities in supporting dapivirine ring use among participants enrolled in the Phase III MTN-020/ASPIRE study

Background: Low adherence to investigational products can negatively impact study outcomes, limit... more Background: Low adherence to investigational products can negatively impact study outcomes, limiting the ability to demonstrate efficacy. To continue advancing potential new HIV prevention technologies for at-risk individuals, efforts are needed to improve adherence among study participants. In MTN-020/ASPIRE, a phase III randomized, double-blind, placebo-controlled study of the dapivirine vaginal ring carried out across 15 sites in sub-Saharan Africa, a multifaceted approach to adherence support was implemented, including a strong focus on participant engagement activities (PEAs). In this manuscript, we describe PEAs and participant attendance, and analyze the potential impact of PEAs on ring use. Methods: All sites implemented PEAs and submitted activity and attendance reports to the study management team throughout the study. Participant demographics were collected via case report forms. Ring use was estimated based on residual dapivirine remaining in the last returned ring by ea...

Research paper thumbnail of Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities

AIDS, 2019

We aimed to determine if the dapivirine vaginal ring and the ring device alone (flexible silicone... more We aimed to determine if the dapivirine vaginal ring and the ring device alone (flexible silicone matrix polymer) was associated with the development of cervical cytology abnormalities. Design: Secondary analysis comparing cervical cytology results between two randomized controlled microbicide trials (ASPIRE and VOICE) Methods: Data from the MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine vaginal ring, were used in this analysis. Cervical cytology smears were evaluated at baseline and at the final visit with product use. We compared cytology results between women randomized to dapivirine versus placebo vaginal ring. We further assessed for the effect of the vaginal ring device on cervical cytology by comparing results with data from the oral placebo arm of MTN-003/VOICE, a prior HIV-1 prevention trial conducted in a similar population. Results: Cervical cytology results for 2394 women from ASPIRE (1197 per study arm) were used in this analysis; median time between baseline and final visit with product use was 22.1 months. Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6% vs. 91.5%, ASC-US//LSIL: 7.8% vs. 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7% vs. 1.1%, p=0.44. Cytology data from VOICE had findings (normal: 87.8%, ASC-US/LSIL: 9.8%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 2.4%) comparable to that of both dapivirine (p=0.93) and placebo vaginal ring arms (p=0.24). Conclusions: These findings indicate that neither use of the dapivirine vaginal ring nor the vaginal ring device alone, over a period of two years, is associated with development of cervical cytology abnormalities that could lead to pre-cancerous or cancerous lesions.

Research paper thumbnail of Risk of HIV-1 acquisition among South African women using a variety of contraceptive methods in a prospective study

AIDS, 2019

Objective-Observational studies have associated use of intramuscular injectable depot medroxyprog... more Objective-Observational studies have associated use of intramuscular injectable depot medroxyprogesterone acetate (DMPA-IM) with increased risk of HIV-1 acquisition, but limited data are available to assess HIV-1 risk for alternate contraceptive methods. Methods-Within a randomized trial of the dapivirine vaginal ring for HIV-1 prevention, we assessed HIV-1 incidence by contraceptive method. We limited analyses to participants from South African sites and to women who used DMPA-IM, the alternative injectable norethisterone enanthate (NET-EN), implants, or copper IUDs. Contraceptive method was assessed as a timedependent exposure and multivariate models adjusted for trial randomization arm, age, sexual behavior, and incident sexually transmitted infections. Results-95 incident HIV-1 infections were observed: incidence 5.8 (DMPA-IM, n=52), 6.2 (NET-EN, n=28), 1.9 (implant, n=3), and 4.5 (IUD, n=12) cases per 100 woman-years. In multivariable models, there were no statistically significant differences between contraceptive methods in the risk of HIV-1 acquisition. However, compared to the IUD, the three hormonal methods each had point estimates near 1 while the implant had risk that was approximately half that of the IUD. When the three hormonal methods were combined, their relative risk compared with IUD was 0.90 (95% confidence interval 0.45-1.76).

Research paper thumbnail of First Impressions Matter: How Initial Worries Influence Adherence to the Dapivirine Vaginal Ring

JAIDS Journal of Acquired Immune Deficiency Syndromes, 2019

Background: In MTN-020/ASPIRE, a dapivirine vaginal ring effectiveness trial in sub-Saharan Afric... more Background: In MTN-020/ASPIRE, a dapivirine vaginal ring effectiveness trial in sub-Saharan Africa, we assessed whether worries about ring use changed over time and were associated with adherence. Methods: Participants (N=2585) were surveyed at baseline and follow-up about worries regarding daily ring use. First, they answered a question about general worries and then responded to 15 items covering specific worries. From a nested qualitative component (N=214), we extracted themes related to ring worries and adherence. Seven months into the trial, aggregate adherence ** A list of the members of the Microbicide Trials Network 020-A Study to Prevent Infection with a Ring for Extended Use (MTN-020-ASPIRE) Study Team is provided in the Acknowledgements section.

Research paper thumbnail of Does the Ring Work? Perceptions and Understanding of the Efficacy of a Dapivirine Vaginal Ring for HIV Prevention Amongst Women in a Placebo-Controlled Trial

AIDS and Behavior, 2021

(MUJHU) in Uganda where the primary author conducted the study, ethical approval was received fro... more (MUJHU) in Uganda where the primary author conducted the study, ethical approval was received from Joint Clinical Research (JCRC) ethics review committee, Uganda National Council for Science and Technology (UNCST) and Johns Hopkins Medicine IRB. All study participants were consented for participation in the study, dissemination and publication of the study findings.

Research paper thumbnail of Women’s experience receiving drug feedback and adherence counseling in MTN-025/HOPE - an HIV Prevention open-label trial of the Dapivirine Vaginal Ring

Research paper thumbnail of Acceptability of the Dapivirine Vaginal Ring in Postmenopausal US Women

AIDS Patient Care and STDs, 2022

For women in the United States who remain sexually active beyond child-bearing years, susceptibil... more For women in the United States who remain sexually active beyond child-bearing years, susceptibility to HIV infection remains, yet condom use is low. We assessed acceptability of the dapivirine vaginal ring (ring) among 96 postmenopausal US women enrolled in a placebo-controlled multisite phase II trial of the ring, using questionnaires and in-depth interviews. Three quarters of women reported ''perfect'' adherence (ring never out) over the 3-month trial period. At study exit, the ring was found to be very easy to use by 72%, very comfortable to wear by 65%, and 4% reported it ever interfered with their daily activities. The most common worries among participants at preinitiation had decreased significantly at study exit (e.g., worries about inserting the ring declined from 46% to 6%, discomfort during daily activities from 53% to 3%, ring not staying in place from 48% to 14%, all p < 0.0001). Despite some couples feeling the ring during sex, the ring was perceived as more suitable than condoms for prevention because it was not burdensome to use, did not interfere with erection, and provided (for some) additional vaginal lubrication. The ring is a promising, highly acceptable HIV prevention method that is suitable to the lives of postmenopausal women and their male partners and can provide them with an additional prevention choice. Clinical Trials Registration: NCT02010593.

Research paper thumbnail of Correlates of Adherence to the Dapivirine Vaginal Ring for HIV-1 Prevention

AIDS and Behavior, 2021

Understanding characteristics associated with adherence to pre-exposure prophylaxis (PrEP) method... more Understanding characteristics associated with adherence to pre-exposure prophylaxis (PrEP) methods for HIV-1 prevention may assist with optimizing implementation efforts. The dapivirine vaginal ring is a novel topical PrEP delivery method. Using data from a randomized, double-blind, placebo-controlled, phase III trial of the dapivirine vaginal ring conducted in four African countries, generalized estimating equation models were used to evaluate correlates of ring adherence. Two levels of quarterly dapivirine blood plasma, and dapivirine released from returned rings defined measures of adherence for recent and cumulative use, respectively. Time on study, calendar time, primary partner knowledge that the participant was taking part in the study, and use of long-acting contraceptive methods were associated with ring adherence whereas younger age, ring worries, condom use, episodes of menstrual bleeding and vaginal washing were associated with non-adherence. These findings may be useful for recruitment into future clinical studies and dapivirine ring implementation efforts.

Research paper thumbnail of How a menu of adherence support strategies facilitated high adherence to HIV prevention products among adolescent girls and young women in sub‐Saharan Africa: a mixed methods analysis

Journal of the International AIDS Society

IntroductionEffective use of pre‐exposure prophylaxis (PrEP) has been low among adolescent girls ... more IntroductionEffective use of pre‐exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in sub‐Saharan Africa. The MTN‐034/REACH trial offered AGYW a menu of adherence support strategies and achieved high adherence to both daily oral PrEP and the monthly dapivirine vaginal ring. Understanding how these strategies promoted product use could inform the design of adherence support systems in programmatic settings.MethodsREACH was a randomized crossover trial evaluating the safety of and adherence to the ring and oral PrEP among 247 HIV‐negative AGYW (ages 16–21) in South Africa, Uganda and Zimbabwe from January 2019 to September 2021 (NCT03593655). Adherence support included monthly counselling sessions with drug‐level feedback (DLF) plus optional daily short message service (SMS) reminders, weekly phone or SMS check‐ins, peer support clubs, “peer buddies” and additional counselling. Counsellors documented adherence support choices and counselling conten...

Research paper thumbnail of Efficacy and Action of the Dapivirine Vaginal Ring as Understood by Women Participating in an Open Label Extension Study

Aids and Behavior, Jun 7, 2022

Research paper thumbnail of Adolescent Girls and Young Women’s Experiences with Disclosing Oral PrEP or Dapivirine Vaginal Ring Use: a Multi-Country Qualitative Analysis

AIDS and Behavior

Effective use of oral pre-exposure prophylaxis (PrEP) has been low among adolescent girls and you... more Effective use of oral pre-exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in Eastern and Southern Africa, partly due to stigma and opposition from key influencers. Understanding AGYW’s experiences of disclosure of different PrEP modalities to key influencers may inform strategies to motivate uptake and adherence. We analyzed qualitative in-depth interviews and focus group discussions data from 119 participants in the MTN-034/REACH (Reversing the Epidemic in Africa with Choices in HIV Prevention) study of oral PrEP and the dapivirine vaginal ring (ring) to explore AGYW’s disclosure experiences. We found that AGYW disclosure experiences varied across influencers and product type. The ring was disclosed less often to most influencers, except partners, because it was discreet. Oral PrEP was disclosed more often, because pills were more common and to avoid HIV stigma given that oral PrEP resembled HIV treatment. Ultimately, disclosure typically led ...

Research paper thumbnail of Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial

JAIDS Journal of Acquired Immune Deficiency Syndromes

BACKGROUND Persistent use of HIV prevention methods can be a challenge, particularly for some you... more BACKGROUND Persistent use of HIV prevention methods can be a challenge, particularly for some younger women. The long-acting, discreet, woman-centric dapivirine vaginal ring offers promise as a prevention method with less user burden, which could support continued use. We assessed dapivirine vaginal ring use to understand adherence patterns and identify characteristics influencing patterns. SETTING Participants enrolled in South Africa in the MTN-020/ASPIRE randomized placebo-controlled trial. METHODS We used group-based trajectory modeling to identify clusters of participants with similar longitudinal patterns of adherence in last year of participation and potential predictors of group membership. Women with at least one year of follow-up were included (n=626). RESULTS Five adherence patterns were identified: (1) consistently high, 34%, (2) consistently moderate, 34%, (3) consistently low, 16%, (4) decreasing, 9%, and (5) increasing, 7%.Women <22 years (adjusted odds ratio [AOR] 1.8, 95% Confidence Interval [CI]: 1.0, 3.0), those using an intrauterine device [AOR 3.3, 95% CI: 1.4, 7.8] or oral contraceptives [AOR 3.9, 95% CI: 1.7, 8.9], experiencing menses [AOR 1.8, 95% CI: 1.1, 3.0] and who reported inconsistent condom use [AOR 1.8, 95% CI: 1.0, 3.3] were more likely to be classified as consistently low compared to consistently high. CONCLUSION Most South African women successfully persisted with moderate or high-level of use. Encouraging ring replacement with completion of menses may help to decrease concerns about hygiene and improve persistence. Associations between contraception and persistent low adherence suggest efforts may be needed to ensure contraceptive method choice does not interfere with ring use.

Research paper thumbnail of Pharmacokinetic cross-over study in women comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other anatomic compartments (MTN-001)

Research paper thumbnail of HPTN 069/ACTG A5305: phase II study of maraviroc-containing regimens for HIV PrEP in US women; Postive impact of a randomized controlled trial of the Uthando Lwethu ("Our Love") intervention on rates of couples HIV testing in rural South Africa

Research paper thumbnail of Chapter 11 Housing and Health: Exploring the Complex Intersections Between Housing Environments and Health Behaviors Among Women Living in Poverty

Poverty in the United States, 2016

Location, quality, and reliability of housing are associated with physical and mental health. Fin... more Location, quality, and reliability of housing are associated with physical and mental health. Financial resources (or lack thereof) and availability of affordable housing may restrict housing choice and mobility. Women, and unmarried women with children in particular, experience greater poverty rates than other groups, and, as a result, are particularly vulnerable to the ill effects of precarious housing conditions. This chapter explores interview and focus group themes as they relate to women’s experiences of their housing environment. The aims of this chapter are to (1) describe the physical attributes of housing where women reside, and the social and built characteristics of the neighborhoods where this housing is situated, and (2) explore how poverty affects housing choice and mobility. Participants felt trapped by marginal living situations resulting from limited housing choice, financial constraints, and transportation needs. Participants believed that their environments affected their physical and emotional well-being and described trade-offs that had immediate and long-term health implications (e.g., exchanging sex for housing, staying in dilapidated housing to keep benefits), and perceived low control over these situations. Women living in poverty require assistance identifying and relocating to safe, affordable housing with adequate transportation access. Programming should be coupled with interventions to increase women’s financial assets and mental health and with reevaluations of policies contributing to poverty and unstable housing.

Research paper thumbnail of Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India

AIDS research and therapy, Jan 20, 2006

The objective of this study was to evaluate the safety of twice daily, intra-vaginal use of 0.5% ... more The objective of this study was to evaluate the safety of twice daily, intra-vaginal use of 0.5% PRO 2000 Gel for fourteen days in HIV un-infected women at lower as well as higher risk for HIV acquisition, in Pune, India. Forty-two eligible volunteers (30 low-risk and 12 high-risk) were given 0.5% PRO 2000 Gel for intra-vaginal application twice daily for 14 consecutive days. Twenty-four participants (57%, 95% CI 41%-72%) experienced at least one adverse event (AE) judged to be possibly related to the product use. There were 17 (40%, 95% CI 26%-57%) mild AEs and 7 (17%, 95% CI 7%-31%) moderate AEs. There were no serious adverse events and no AEs judged probably or definitely related to product use. Genitourinary discomfort was reported by 2/30 (6.67%) participants in the low-risk cohort as compared to 4/12 (33.3%) women in the high-risk cohort (p = 0.03). Intermenstrual bleeding was reported in 2/30 (6.7%, 95% CI 1.0-22.1) women from the low risk cohort and 3/12 (25%, 95% CI 5.5-57....

Research paper thumbnail of Baseline preferences for oral pre-exposure prophylaxis (PrEP) or dapivirine intravaginal ring for HIV prevention among adolescent girls and young women in South Africa, Uganda and Zimbabwe (MTN-034/IPM-045 study)

PLOS ONE

Introduction Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately... more Introduction Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately affected by the HIV epidemic and face an array of challenges using proven behavioral and biomedical prevention methods. To address the urgent need for expanding prevention options, we evaluated the baseline preferences of HIV prevention methods among participants enrolled in the MTN-034/REACH crossover trial along with their stated product preference prior to product initiation. Methods AGYW aged 16–21 years were enrolled at 4 study sites: Cape Town and Johannesburg, South Africa; Kampala, Uganda; and Harare, Zimbabwe and randomly assigned to the sequence of using oral PrEP and the dapivirine ring for 6 months each, followed by a choice period in which they could choose either product (or neither) for an additional six months. Eligible AGYW were HIV-negative, not pregnant and using effective contraception for at least two months prior to enrollment. Descriptive statistics were used to s...

Research paper thumbnail of Sexual Behaviors of US Women at Risk of HIV Acquisition: A Longitudinal Analysis of Findings from HPTN 064

AIDS and behavior, Jan 29, 2015

We describe the sexual behaviors of women at elevated risk of HIV acquisition who reside in areas... more We describe the sexual behaviors of women at elevated risk of HIV acquisition who reside in areas of high HIV prevalence and poverty in the US. Participants in HPTN 064, a prospective HIV incidence study, provided information about individual sexual behaviors and male sexual partners in the past 6 months at baseline, 6- and 12-months. Independent predictors of consistent or increased temporal patterns for three high-risk sexual behaviors were assessed separately: exchange sex, unprotected anal intercourse (UAI) and concurrent partnerships. The baseline prevalence of each behavior was >30 % among the 2,099 participants, 88 % reported partner(s) with >1 HIV risk characteristic and both individual and partner risk characteristics decreased over time. Less than high school education and food insecurity predicted consistent/increased engagement in exchange sex and UAI, and partner's concurrency predicted participant concurrency. Our results demonstrate how interpersonal and soc...

Research paper thumbnail of Correlates of Dapivirine Vaginal Ring Acceptance among Women Participating in an Open Label Extension Trial

Research paper thumbnail of Does the ring work? Perceptions and understandings of the efficacy of a vaginal ring for HIV prevention amongst women participating in the MTN-032/AHA study

HIV Research for Prevention 2021, Jan 26, 2021

Research paper thumbnail of The impact of participant engagement activities in supporting dapivirine ring use among participants enrolled in the Phase III MTN-020/ASPIRE study

Background: Low adherence to investigational products can negatively impact study outcomes, limit... more Background: Low adherence to investigational products can negatively impact study outcomes, limiting the ability to demonstrate efficacy. To continue advancing potential new HIV prevention technologies for at-risk individuals, efforts are needed to improve adherence among study participants. In MTN-020/ASPIRE, a phase III randomized, double-blind, placebo-controlled study of the dapivirine vaginal ring carried out across 15 sites in sub-Saharan Africa, a multifaceted approach to adherence support was implemented, including a strong focus on participant engagement activities (PEAs). In this manuscript, we describe PEAs and participant attendance, and analyze the potential impact of PEAs on ring use. Methods: All sites implemented PEAs and submitted activity and attendance reports to the study management team throughout the study. Participant demographics were collected via case report forms. Ring use was estimated based on residual dapivirine remaining in the last returned ring by ea...

Research paper thumbnail of Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities

AIDS, 2019

We aimed to determine if the dapivirine vaginal ring and the ring device alone (flexible silicone... more We aimed to determine if the dapivirine vaginal ring and the ring device alone (flexible silicone matrix polymer) was associated with the development of cervical cytology abnormalities. Design: Secondary analysis comparing cervical cytology results between two randomized controlled microbicide trials (ASPIRE and VOICE) Methods: Data from the MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine vaginal ring, were used in this analysis. Cervical cytology smears were evaluated at baseline and at the final visit with product use. We compared cytology results between women randomized to dapivirine versus placebo vaginal ring. We further assessed for the effect of the vaginal ring device on cervical cytology by comparing results with data from the oral placebo arm of MTN-003/VOICE, a prior HIV-1 prevention trial conducted in a similar population. Results: Cervical cytology results for 2394 women from ASPIRE (1197 per study arm) were used in this analysis; median time between baseline and final visit with product use was 22.1 months. Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6% vs. 91.5%, ASC-US//LSIL: 7.8% vs. 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7% vs. 1.1%, p=0.44. Cytology data from VOICE had findings (normal: 87.8%, ASC-US/LSIL: 9.8%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 2.4%) comparable to that of both dapivirine (p=0.93) and placebo vaginal ring arms (p=0.24). Conclusions: These findings indicate that neither use of the dapivirine vaginal ring nor the vaginal ring device alone, over a period of two years, is associated with development of cervical cytology abnormalities that could lead to pre-cancerous or cancerous lesions.

Research paper thumbnail of Risk of HIV-1 acquisition among South African women using a variety of contraceptive methods in a prospective study

AIDS, 2019

Objective-Observational studies have associated use of intramuscular injectable depot medroxyprog... more Objective-Observational studies have associated use of intramuscular injectable depot medroxyprogesterone acetate (DMPA-IM) with increased risk of HIV-1 acquisition, but limited data are available to assess HIV-1 risk for alternate contraceptive methods. Methods-Within a randomized trial of the dapivirine vaginal ring for HIV-1 prevention, we assessed HIV-1 incidence by contraceptive method. We limited analyses to participants from South African sites and to women who used DMPA-IM, the alternative injectable norethisterone enanthate (NET-EN), implants, or copper IUDs. Contraceptive method was assessed as a timedependent exposure and multivariate models adjusted for trial randomization arm, age, sexual behavior, and incident sexually transmitted infections. Results-95 incident HIV-1 infections were observed: incidence 5.8 (DMPA-IM, n=52), 6.2 (NET-EN, n=28), 1.9 (implant, n=3), and 4.5 (IUD, n=12) cases per 100 woman-years. In multivariable models, there were no statistically significant differences between contraceptive methods in the risk of HIV-1 acquisition. However, compared to the IUD, the three hormonal methods each had point estimates near 1 while the implant had risk that was approximately half that of the IUD. When the three hormonal methods were combined, their relative risk compared with IUD was 0.90 (95% confidence interval 0.45-1.76).

Research paper thumbnail of First Impressions Matter: How Initial Worries Influence Adherence to the Dapivirine Vaginal Ring

JAIDS Journal of Acquired Immune Deficiency Syndromes, 2019

Background: In MTN-020/ASPIRE, a dapivirine vaginal ring effectiveness trial in sub-Saharan Afric... more Background: In MTN-020/ASPIRE, a dapivirine vaginal ring effectiveness trial in sub-Saharan Africa, we assessed whether worries about ring use changed over time and were associated with adherence. Methods: Participants (N=2585) were surveyed at baseline and follow-up about worries regarding daily ring use. First, they answered a question about general worries and then responded to 15 items covering specific worries. From a nested qualitative component (N=214), we extracted themes related to ring worries and adherence. Seven months into the trial, aggregate adherence ** A list of the members of the Microbicide Trials Network 020-A Study to Prevent Infection with a Ring for Extended Use (MTN-020-ASPIRE) Study Team is provided in the Acknowledgements section.

Research paper thumbnail of Does the Ring Work? Perceptions and Understanding of the Efficacy of a Dapivirine Vaginal Ring for HIV Prevention Amongst Women in a Placebo-Controlled Trial

AIDS and Behavior, 2021

(MUJHU) in Uganda where the primary author conducted the study, ethical approval was received fro... more (MUJHU) in Uganda where the primary author conducted the study, ethical approval was received from Joint Clinical Research (JCRC) ethics review committee, Uganda National Council for Science and Technology (UNCST) and Johns Hopkins Medicine IRB. All study participants were consented for participation in the study, dissemination and publication of the study findings.

Research paper thumbnail of Women’s experience receiving drug feedback and adherence counseling in MTN-025/HOPE - an HIV Prevention open-label trial of the Dapivirine Vaginal Ring

Research paper thumbnail of Acceptability of the Dapivirine Vaginal Ring in Postmenopausal US Women

AIDS Patient Care and STDs, 2022

For women in the United States who remain sexually active beyond child-bearing years, susceptibil... more For women in the United States who remain sexually active beyond child-bearing years, susceptibility to HIV infection remains, yet condom use is low. We assessed acceptability of the dapivirine vaginal ring (ring) among 96 postmenopausal US women enrolled in a placebo-controlled multisite phase II trial of the ring, using questionnaires and in-depth interviews. Three quarters of women reported ''perfect'' adherence (ring never out) over the 3-month trial period. At study exit, the ring was found to be very easy to use by 72%, very comfortable to wear by 65%, and 4% reported it ever interfered with their daily activities. The most common worries among participants at preinitiation had decreased significantly at study exit (e.g., worries about inserting the ring declined from 46% to 6%, discomfort during daily activities from 53% to 3%, ring not staying in place from 48% to 14%, all p < 0.0001). Despite some couples feeling the ring during sex, the ring was perceived as more suitable than condoms for prevention because it was not burdensome to use, did not interfere with erection, and provided (for some) additional vaginal lubrication. The ring is a promising, highly acceptable HIV prevention method that is suitable to the lives of postmenopausal women and their male partners and can provide them with an additional prevention choice. Clinical Trials Registration: NCT02010593.

Research paper thumbnail of Correlates of Adherence to the Dapivirine Vaginal Ring for HIV-1 Prevention

AIDS and Behavior, 2021

Understanding characteristics associated with adherence to pre-exposure prophylaxis (PrEP) method... more Understanding characteristics associated with adherence to pre-exposure prophylaxis (PrEP) methods for HIV-1 prevention may assist with optimizing implementation efforts. The dapivirine vaginal ring is a novel topical PrEP delivery method. Using data from a randomized, double-blind, placebo-controlled, phase III trial of the dapivirine vaginal ring conducted in four African countries, generalized estimating equation models were used to evaluate correlates of ring adherence. Two levels of quarterly dapivirine blood plasma, and dapivirine released from returned rings defined measures of adherence for recent and cumulative use, respectively. Time on study, calendar time, primary partner knowledge that the participant was taking part in the study, and use of long-acting contraceptive methods were associated with ring adherence whereas younger age, ring worries, condom use, episodes of menstrual bleeding and vaginal washing were associated with non-adherence. These findings may be useful for recruitment into future clinical studies and dapivirine ring implementation efforts.