Acceptability of a dapivirine levonorgestrel vaginal ring in two Phase 1 trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019): Implications for multipurpose prevention technology development.

End-user feedback early in product development is important for optimizing multipurpose prevention technologies for HIV and pregnancy prevention. We evaluated the acceptability of the 90-day dapivirine levonorgestrel ring (DPV-LNG ring) used for 14 days compared to a dapivirine-only ring (DVR-200mg) in MTN-030/IPM 041 (n = 23), and when used for 90 days cyclically or continuously in MTN-044/IPM 053/CCN019 (n = 25). We enrolled healthy, non-pregnant, HIV-negative women aged 18-45 in Pittsburgh, PA and Birmingham, AL (MTN-030 only).

Policies and interventions to remove gender-related barriers to girls' school participation and learning in low- and middle-income countries: A systematic review of the evidence.

Background: Gender disparities in education continue to undermine girls' opportunities, despite enormous strides in recent years to improve primary enrolment and attainment for girls in low- and middle-income countries (LMICs). At the regional, country and subnational levels gender gaps remain, with girls in many settings less likely to complete primary school, less likely to complete secondary, and often less likely to be literate than boys. The academic and policy literatures on the topic of gender-related barriers to girls' education are both extensive.

Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial.

The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined acceptability and preference for 3-month versus 1-month rings for HIV-1 risk reduction in a phase 1 clinical trial. In Microbicide Trials Network-036/International Partnership for Microbicides 047, 49 HIV-negative participants aged 18-45 were randomized to one of two 3-month rings or the 1-month ring.

Application of a Body Map Tool to Enhance Discussion of Sexual Behavior in Women in South Africa, Uganda, and Zimbabwe.

Body mapping methods are used in sexual and reproductive health studies to encourage candid discussion of sex and sexuality, pleasure and pain, sickness and health, and to understand individuals' perceptions of their bodies. VOICE-D, a qualitative follow-up study to the VOICE trial, developed and used a body map tool in the context of individual in-depth interviews with women in South Africa, Uganda, and Zimbabwe. The tool showed the outline of a nude female figure from the front and back perspective.

Qualitative Study on the Acceptability of and Adherence to a Vaginal Ring for HIV Prophylaxis Among Adolescent Girls.

Objective: This study aims to assess the product-related, relationship-related, and sex-related factors that act as facilitators and barriers to the acceptability of a vaginal ring (VR) for HIV prevention among adolescent girls.

Design: Qualitative study.

Methods: Ninety-six girls aged 15-17 years from 6 urban US sites were enrolled in MTN-023/IPM 030, a 24-week randomized controlled trial, for assessing the safety and acceptability of a dapivirine VR for HIV prevention.

Does schooling protect sexual health? The association between three measures of education and STIs among adolescents in Malawi.

While multiple studies have documented shifting educational gradients in HIV prevalence, less attention has been given to the effect of school participation and academic skills on infection during adolescence. Using the Malawi Schooling and Adolescent Study, a longitudinal survey that followed 2,649 young people aged 14-17 at baseline from 2007 to 2013, we estimate the effect of three education variables: school enrolment, grade attainment, and academic skills-numeracy and Chichewa literacy-on herpes simplex virus type 2 (HSV-2) and HIV incidence using interval-censored survival analysis. We find that grade attainment is significantly associated with lower rates of both HSV-2 and HIV among girls, and is negatively associated with HSV-2 but not HIV among boys.

The Effects of Adolescent Childbearing on Literacy and Numeracy in Bangladesh, Malawi, and Zambia.

Global investments in girls' education have been motivated, in part, by an expectation that more-educated women will have smaller and healthier families. However, in many low- and middle-income countries, the timing of school dropout and first birth coincide, resulting in a rapid transition from the role of student to the role of mother for adolescent girls. Despite growing interest in the effects of pregnancy on levels of school dropout, researchers have largely overlooked the potential effect of adolescent childbearing on literacy and numeracy.

Causal effects of education on sexual and reproductive health in low and middle-income countries: A systematic review and meta-analysis.

Background: Despite strong theoretical grounding, important gaps in knowledge remain regarding the degree to which there is a causal relationship between education and sexual and reproductive health, as many claims have been made based on associations alone. Understanding the extent to which these relationships are causal is important both to inform investments in education and health, as well as to understand the mechanisms underlying these relationships.

Methods: We conducted a systematic review of the evidence for a causal link between education and sexual and reproductive health (SRH) in low and middle-income countries.

First Impressions Matter: How Initial Worries Influence Adherence to the Dapivirine Vaginal Ring.

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.

Evidence for causal links between education and maternal and child health: systematic review.

Objective: Numerous studies have documented an inverse association between years of schooling attained, particularly by women, and reduced maternal, infant and child mortality. However, if factors affecting educational attainment - many of which are unobservable, e.g.

Understanding women's motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence.

Background: In biomedical prevention trials, correct and consistent use of the investigational product is crucial to determine efficacy. Product adherence in VOICE, a phase 2B randomized trial of a vaginal gel and oral tablets for HIV prevention, was low (~ 34%), yet self-reported adherence and retention was high (> 90%). This analysis from VOICE-D, a post-trial qualitative ancillary study, explores motivations to participate in VOICE, and possible sources of misalignment between the stated priorities of the trial and the participants.

Debrief Reports to Expedite the Impact of Qualitative Research: Do They Accurately Capture Data from In-depth Interviews?

"Debrief reports" (DRs) use structured forms to capture key concepts from in-depth interviews and focus group discussions. They are completed by interviewers and rapidly disseminated to key team members to facilitate identification of potential problems with study procedures, recruitment, or participant engagement and to inform critical adjustments, which can be especially pertinent in intervention studies. Their reliability and validity have yet to be formally evaluated.

Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE.

This analysis compares self-reports of product use with objective measures of non-adherence-quarterly plasma dapivirine levels and monthly residual dapivirine (DPV) levels in used rings-in MTN-020/ASPIRE, a phase 3 trial of a monthly DPV vaginal ring among women aged 18-45 years in Malawi, South Africa, Uganda and Zimbabwe. For participants on active product (N = 1211) we assessed self-reported monthly non-adherence, as measured by (1) whether the ring was ever out, and out for ≥ 12 h in the previous month and, (2) by a self-rating scale assessing ability to keep the vaginal ring inserted, and compared the self-reports to two biomarkers of non-use separately and as a composite measure. For this analysis, a plasma DPV value ≤ 95 pg/ml and residual ring ≥ 23.

Associations between violence in school and at home and education outcomes in rural Malawi: A longitudinal analysis.

Growing evidence of the prevalence of school-related gender-based violence (SRGBV) has raised concerns about negative effects on education. Previous quantitative research on this topic has been limited by descriptive and cross-sectional data. Using longitudinal data from the Malawi Schooling and Adolescent Study, we investigate associations between school and domestic violence and three education outcomes: absenteeism, learning and dropout.

Trends in the age at reproductive transitions in the developing world: The role of education.

Girls' school participation has expanded considerably in the developing world over the last few decades, a phenomenon expected to have substantial consequences for reproductive behaviour. Using Demographic and Health Survey data from 43 countries, this paper examines trends and differentials in the mean ages at three critical life-cycle events for young women: first sexual intercourse, first marriage, and first birth. We measure the extent to which trends in the timing of these events are driven either by the changing educational composition of populations or by changes in behaviour within education groups.

How Presentation of Drug Detection Results Changed Reports of Product Adherence in South Africa, Uganda and Zimbabwe.

Accurate estimates of study product use are critical to understanding and addressing adherence challenges in HIV prevention trials. The VOICE trial exposed a significant gap between self-reported adherence and drug detection. The VOICE-D qualitative study was designed to better understand non-adherence during VOICE, and was conducted in 2 stages: before (stage 1) and after (stage 2) drug detection results were provided to participants.

Achieving the optimal vaginal state: using vaginal products and study gels in Uganda, Zimbabwe, and South Africa.

Preferences and practices related to the vaginal condition have implications for the use of vaginal HIV prevention products. We used qualitative methods to explore narratives relating to the vaginal state amongst women in South Africa, Uganda and Zimbabwe who had previously participated in a biomedical HIV prevention trial. We investigated women's behaviours related to optimising the vaginal state, experiences and perceptions of the gel's effect on the vaginal state and on penile-vaginal intercourse, women's narratives on male partner perceptions, and how preferences relating to the vaginal state may have interfered with gel use.

Correlates of Contraceptive Use and Health Facility Choice among Young Women in Malawi.

We explore whether differential access to family planning services and the quality of those services explain variability in uptake of contraception among young women in Malawi. We accomplish this by linking the Malawi Schooling and Adolescent Study, a longitudinal survey of young people, with the Malawi Service Provision Assessment collected in 2013-2014. We also identify factors that determine choice of facility among those who use contraception.

Performance of Kalon herpes simplex virus 2 assay using dried blood spots among young women in Uganda.

The study evaluated the performance of the Kalon HSV-2 assay on dried blood spots (DBS) of various dilutions compared with plasma from young women aged 18-24 years in Uganda. We estimated the sensitivity and specificity of three DBS dilutions using plasma as the reference. All three evaluated DBS dilutions yielded low sensitivities and specificities with DBS 1:2 yielding the highest concurrence.

Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

VOICE-a phase 2B, placebo-controlled, randomized trial testing daily use of an antiretroviral tablet (tenofovir or Truvada) or daily use of tenofovir gel in 5029 women from South Africa, Uganda, and Zimbabwe-found none of the drug regimens effective in reducing HIV-1 acquisition in the intent-to-treat analysis. More than half of women assigned to active products in a case cohort sample had no drug detected in any plasma specimens tested during the trial. Yet, in response to questions asked of participants during the trial, ≥90 % of doses were reportedly taken.

Women's Perceptions and Misperceptions of Male Circumcision: A Mixed Methods Study in Zambia.

Women's perceptions of male circumcision (MC) have implications for behavioral risk compensation, demand, and the impact of MC programs on women's health. This mixed methods study combines data from the first two rounds of a longitudinal study (n = 934) and in-depth interviews with a subsample of respondents (n = 45) between rounds. Most women correctly reported that MC reduces men's risk of HIV (64% R1, 82% R2).

Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women.

Background: Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection.

Disclosure of pharmacokinetic drug results to understand nonadherence.

Objectives: In VOICE, a phase IIB trial of daily oral and vaginal tenofovir for HIV prevention, at least 50% of women receiving active products had undetectable tenofovir in all plasma samples tested. MTN-003D, an ancillary study using in-depth interviews (IDIs) and focus group discussions (FGDs), together with retrospective disclosure of plasma tenofovir pharmacokinetic results, explored adherence challenges during VOICE.

Methods: We systematically recruited participants with pharmacokinetic data (median six plasma samples), categorized as low (0%, N = 79), inconsistent (1-74%, N = 28) or high (≥75%; N = 20) on the basis of frequency of tenofovir detection.