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. School enrolment and academic skills are not significantly associated with sexually transmitted infections (STIs) for boys or girls in our final models. Efforts to encourage school progression in high-prevalence settings in sub-Saharan Africa could well reduce, or at least postpone, acquisition of STIs.

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. METHODS: We conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe. RESULTS: Among the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0.046) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P=0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P<0.001) but not among those 21 years of age or younger (-27%; 95% CI, -133 to 31; P=0.45), a difference that was correlated with reduced adherence. The rates of adverse medical events and antiretroviral resistance among women who acquired HIV-1 infection were similar in the two groups. CONCLUSIONS: A monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01617096 .).

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. motivation and genetic endowment - also affect the likelihood of engaging in behaviours that enhance health, then assumed effects of schooling will be inflated in analyses that do not address this endogeneity. This systematic review assesses evidence for a causal link between education and maternal and child health in low and middle-income countries. METHODS: Eligible studies controlled for observable and unobservable factors affecting both education and health. Reported effects were converted into partial correlations. When possible, we also conducted meta-analyses to estimate mean effects by outcome. RESULTS: Of 4952 papers identified, 16 met the inclusion criteria. The 15 child health papers examined neonatal, infant and child mortality, stunting and wasting. Significant effects of education on infant and child health were observed for 30 of 33 models that did not account for endogeneity. In contrast, only 18 of 46 effects were significant in models that addressed endogeneity. Notably, for only one outcome -child mortality measured dichotomously -was the effect of maternal educational attainment significant in a meta-analysis. The one maternal morbidity paper found significant effects for the two preventable outcomes considered. CONCLUSION: While we find evidence for a causal link between education and health, effects are weaker in models that address endogeneity compared to naïve models that do not account for unobservable factors affecting both education and health. Advances in women's educational outcomes have undoubtedly played a role in improving health in many settings; however, the effect is not as strong as some researchers and advocates have claimed.

OBJECTIF: De nombreuses études ont montré une association inverse entre le nombre d'années de scolarité atteintes, en particulier par les femmes, et la réduction de la mortalité maternelle, infantile et des nourrissons. Cependant, si les facteurs affectant le niveau d'éducation - dont beaucoup sont non observables, tels que la motivation et le patrimoine génétique - affectent également la probabilité d'adopter des comportements qui améliorent la santé, les effets supposés de la scolarité seront alors gonflés dans des analyses ne traitant pas de cette endogénicité. Cette analyse systématique évalue la preuve d'un lien de causalité entre l'éducation et la santé maternelle et infantile dans les pays à revenu faible ou intermédiaire. MÉTHODES: Les études éligibles contrôlaient les facteurs observables et non observables affectant à la fois l'éducation et la santé. Les effets rapportés ont été convertis en corrélations partielles. Dans la mesure du possible, nous avons également effectué des méta-analyses pour estimer les effets moyens par résultat. RÉSULTATS: Sur 4.952 articles identifiés, 16 répondaient aux critères d'inclusion. Les 15 articles sur la santé infantile ont examiné la mortalité néonatale, infantile et du nourrisson, le retard de croissance et l'émaciation. Des effets significatifs de l'éducation sur la santé du nourrisson et de l'enfant ont été observés pour 30 des 33 modèles qui n'ont pas tenu compte de l'endogénicité. En revanche, seuls 18 des 46 effets étaient significatifs dans les modèles traitant de l'endogénicité. Notamment, pour un seul résultat - la mortalité infantile mesurée de manière dichotomique - dans une méta-analyse, l'effet du niveau d'éducation de la mère était significatif. Le seul article sur la morbidité maternelle a révélé des effets significatifs sur les deux résultats évitables considérés. CONCLUSION: Bien que nous trouvons des preuves d'un lien de causalité entre l'éducation et la santé, les effets des modèles qui traitent de l'endogénicité sont plus faibles que ceux des modèles naïfs qui ne tiennent pas compte de facteurs non observables affectant à la fois l'éducation et la santé. Les progrès dans les résultats scolaires des femmes ont incontestablement joué un rôle dans l'amélioration de la santé dans de nombreux contextes; cependant, l'effet n'est pas aussi puissant que certains chercheurs et défenseurs le prétendent.

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. To assess the accuracy of DRs in capturing key content, raters analyzed a random sub-sample of 20 pairs of de-identified transcripts and their linked DRs from the VOICE-D trial. Analyses generally supported the accuracy of DRs; however, pertinent information from transcripts was occasionally missed or recorded with discrepancies or lack of detail. Longer transcripts and DR sections describing complex topic areas were more likely to involve discrepancies. Recommendations are offered for further research and optimizing the use of DRs.

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 ≥ 23.5 mg were used to classify non-adherence (i.e. the ring never being in the vagina the previous month). Compared to self-reports, non-adherence was found to be substantially higher for the composite measure as well as its two components, an indication that ring removal was likely underreported in the trial. The discrepancy between the self-report measure of ring outage and the composite indicator was greater for those aged 18-21 than for those older, evidence that younger women are more likely to underreport non-adherence. Despite underreporting of non-adherence, self-reports of the ring never being out were significant in predicting the composite objective measure. Furthermore, the association between the self-rating scale and the objective measure was in the expected direction and significant, although 11% of those 18-21 and 7% of those 22+ who rated their ability to keep the ring inserted as good, very good or excellent in the 4 weeks prior to exit were considered non-adherent according to the objective measure. This analysis indicates that while self-reports are significantly associated with objective measures of adherence in the ASPIRE trial, they were inflated-more so by those younger-and therefore may have limited utility identifying those who have challenges using products as directed. ClinicalTrials.gov number NCT01617096.

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. We hypothesize that becoming a mother soon after leaving school may cause the deterioration of skills gained in school. Using longitudinal data from Bangladesh, Malawi, and Zambia, we test our hypothesis by estimating fixed-effects linear regression models to address the endogeneity in the relationship between childbearing and academic skills. To our knowledge, this is the first study to examine the effects of adolescent childbearing on academic skills in low- and middle-income countries. Our results indicate that among those with low levels of grade attainment, first birth has a negative effect on English literacy and numeracy. Among those with higher levels of grade attainment, we find little evidence of effects of childbearing on academic skills. Childbearing also has little effect on local language literacy. Beyond the immediate loss of English literacy and numeracy, if these skills lead to better health and more economic productivity, then adolescent childbearing may have longer-term repercussions than previously understood. In addition to ongoing efforts to increase educational attainment and school quality in low- and middle-income countries, investments are needed to strengthen the academic skills of adolescent mothers to secure the demographic and economic promise of expanded education for girls and women.

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. METHODS: VOICE-D enrolled 171 former VOICE participants to investigate, among other things, reasons for joining and remaining in the trial. Local language in-depth interviews and focus groups were transcribed and translated into English and coded and analyzed using NVivo. Data on motivation to join obtained from a VOICE termination visit survey of 106 participants were also analyzed to corroborate the VOICE-D findings. RESULTS: Participants primarily participated for personal health benefits (e.g. free healthcare and HIV testing) and reported remaining enrolled from a sense of commitment to the trial. Altruistic motivations were the most commonly stated motivation on the termination visit survey; qualitatively, many of those stating altruistic reasons also desired personal health benefits. Joining for financial reimbursement was not commonly mentioned. Social networks influenced recruitment and spread therapeutic misconception. CONCLUSIONS: Women's participation for personal health benefits highlighted their desire to monitor their HIV risk and overall health. Helping participants view use of investigational products as improving social capital and reminding participants of their study responsibilities may improve trial outcomes. Understanding the reasons for participating in studies will help to ensure alignment between priorities of researchers and participants. TRIAL REGISTRATION: NCT02358616 ; Posted February 9, 2015, retrospectively registered.

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. Transcripts from 44 women who participated in both stages were analysed to understand the effect of presenting drug detection data on narratives of product use. Thirty-six women reported high adherence in stage 1, yet admitted non-use in stage 2, three reported high adherence in both stages (contrary to their drug detection results) and five had consistent responses across both stages and drug results. Presenting objective measures of use may facilitate more accurate product use reporting and should be evaluated in future prevention trials.

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. Mean ages have risen over time in all regions for all three events, except age at first sex in Latin America and the Caribbean. Results from a decomposition exercise indicate that increases in educational attainment, rather than trends within education groups, are primarily responsible for the overall trends. Possible explanations for these findings are discussed.

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. We find that the presence and characteristics of nearby facilities with contraception available did not appear to affect use. Rather, characteristics such as facility type and whether contraception was provided free of charge determined where women deciding to use contraception obtained their contraception. We argue that in a context where almost all respondents resided within 10 kilometers of a health facility, improving access to and quality of family planning services may not markedly increase contraceptive use among young women without broader shifts in norms regarding childbearing in the early years of marriage.

Condoms, Lubricants and Rectal Cleansing: Practices Associated with Heterosexual Penile-Anal Intercourse Amongst Participants in an HIV Prevention Trial in South Africa, Uganda and Zimbabwe.

We investigated condom and lubricant use, rectal cleansing and rectal gel use for penile-anal intercourse (PAI), during in-depth interviews with women from South Africa, Uganda and Zimbabwe who formerly participated in VOICE, a five-arm HIV prevention trial of two antiretroviral tablets and a vaginal gel. Few studies have addressed practices related to PAI among women; existing data from Africa on condom and lubricant use for PAI, as well as preparatory practices of PAI such as rectal cleansing, are limited to men who have sex with men. Women demonstrated a lack of awareness of HIV transmission risks of PAI and none of the participants reported using condom-compatible lubricants for PAI. Participants described a variety of preparatory rectal cleansing practices. Some participants disclosed rectal use of the vaginal study gel. Understanding practices related to PAI in Africa is critical to microbicide development, as these practices are likely to influence the acceptability, feasibility, and use of both vaginal and rectal microbicide products.

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. To explore factors associated with low adherence, a behavioral termination visit questionnaire was developed after early closure of the oral tenofovir and vaginal gel arms. We hypothesized that participants would be more forthcoming about nonuse after they exited the trial than during monthly/quarterly follow-up visits. Comparison of adherence reporting at routine follow-up visits with reporting at trial termination, however, indicates that disclosure of product nonadherence did not increase at the termination visit as anticipated. In resource-limited settings where women value the ancillary benefits provided by trial participation and are concerned that disclosure of nonuse may jeopardize trial participation, objective measures of adherence may yield more meaningful data regarding the inability or reluctance to use than measures of product use derived from self-report.

Sexual scripting of heterosexual penile-anal intercourse amongst participants in an HIV prevention trial in South Africa, Uganda and Zimbabwe.

Sexual risk-taking is influenced by individual, interpersonal and social factors. This paper presents findings from a qualitative follow-up study to a clinical trial evaluating biomedical HIV prevention products among African women, explored participants' perceptions and experiences of heterosexual penile-anal intercourse, as well as the gendered power dynamics and relationship contexts in which this sexual behaviour occurs. In-depth interviews were conducted with 88 women from South Africa, Uganda and Zimbabwe. Findings reveal that despite its social stigmatisation, women engage in penile-anal intercourse for reasons including male pleasure, relationship security, hiding infidelity, menstruation, vaginal infections, money and beliefs that it will prevent HIV transmission. In addition, participants described experiences of non-consensual penile-anal intercourse. We used sexual scripting theory as an analytical framework with which to describe the sociocultural and relationship contexts and gendered power dynamics in which these practices occur. These data on the distinct individual, dyadic and social contexts of heterosexual penile-anal intercourse, and the specific factors that may contribute to women's HIV risk, make a unique contribution to our understanding of heterosexual behaviour in these sub-Saharan countries, thereby helping to inform both current and future HIV prevention efforts for women in the region.

Using a 2-stage strategy with respondent-driven sampling to recruit a hard-to-reach population for a placebo microbicide gel clinical trial in Nellore, Andhra Pradesh (India).

Traditional recruitment methods for microbicide efficacy trials are labor intensive and may fail to reach high-risk hard-to-reach populations. We report duration of recruitment and lessons learned from a two-stage process to recruit female sex workers (FSWs) into a placebo microbicide trial, and examined characteristics associated with successful recruitment of peers who screened for and enrolled in the trial. FSWs were first recruited via respondent-driven sampling (RDS) to complete a survey and subsequently invited to screen for enrollment into a placebo microbicide trial taking place at a local clinic. It took 6 months to enroll 267 participants into the trial. Successful recruiters of peers who enrolled were more likely to have enrolled themselves (AOR 2.0, CI 1.3-2.9) and less likely to visit Nellore city (AOR 0.5, CI 0.3-0.9). Recruitment of FSWs via a two-stage recruitment strategy with RDS can be a good option for future clinical trials.

Characteristics Associated with HIV Drug Resistance Among Women Screening for an HIV Prevention Trial in KwaZulu-Natal, South Africa.

While the expansion of antiretroviral therapy (ART) in sub-Saharan Africa has reduced morbidity and mortality from HIV/AIDS, it has increased concern about drug resistance. The Microbicide Trials Network 009 study assessed the prevalence of drug-resistance mutations among women at clinical sites in Durban, South Africa who tested seropositive for HIV-1 at screening for the VOICE trial. The objective of this paper was to identify characteristics and behaviors associated with drug resistance. Factors found to be significantly associated with increased resistance were high perceived risk of getting HIV and prior participation in a microbicide trial, a likely proxy for familiarity with the health care system. Two factors were found to be significantly associated with reduced resistance: having a primary sex partner and testing negative for HIV in the past year. Other variables hypothesized to be important in identifying women with resistant virus, including partner or friend on ART who shared with the participant and being given antiretrovirals during pregnancy or labor, or the proxy variable-number of times given birth in a health facility-were not significantly associated. The small number of participants with resistant virus and the probable underreporting of sensitive behaviors likely affected our ability to construct a comprehensive profile of the type of HIV-positive women at greatest risk of developing resistance mutations.

Herpes simplex virus type 2 cross-sectional seroprevalence and the estimated rate of neonatal infections among a cohort of rural Malawian female adolescents.

OBJECTIVE: To assess herpes simplex virus type 2 (HSV-2) seroprevalence among rural Malawian adolescent women and estimate the number of neonatal herpes infections among infants of these adolescents. METHODS: A longitudinal cohort study of adolescents (14-16 years at entry) residing in rural Malawi was initiated in 2007 with annual observation. HSV-2 testing was introduced in 2010. In this study, we (1) determined, using cross-sectional analysis, risk factors for positive serostatus, (2) adjusted for non-response bias with imputation methods and (3) estimated the incidence of neonatal herpes infection using mathematical models. RESULTS: A total of 1195 female adolescents (age 17-20 years) were interviewed in 2010, with an observed HSV-2 seroprevalence of 15.2% among the 955 women tested. From a multivariate analysis, risk factors for HSV-2 seropositivity include older age (p=0.037), moving from the baseline village (p=0.020) and report of sexual activity with increasing number of partners (p<0.021). Adjusting for non-response bias, the estimated HSV-2 seroprevalence among the total female cohort (composed of all women interviewed in 2007) was 18.0% (95% CI 16.0% to 20.2%). HSV-2 seropositivity was estimated to be 25.6% (95% CI 19.6% to 32.5%) for women who refused to provide a blood sample. The estimated number of neonatal herpes infections among the total female cohort was 71.8 (95% CI 57.3 to 86.3) per 100 000 live births. CONCLUSIONS: The risk of HSV-2 seroconversion is high during adolescence, when childbearing is beginning, among rural Malawian women. Research on interventions to reduce horizontal and vertical HSV-2 transmission during adolescence in resource-limited settings is needed.

Evaluation of 3 approaches for assessing adherence to vaginal gel application in clinical trials.

BACKGROUND: Accurate measurement of adherence to product use is an ongoing challenge in microbicide trials. METHODS: We compared adherence estimates using 2 applicator tests (a dye stain assay [DSA] and an ultraviolet light assay [UVA]), the Wisebag (an applicator container that electronically tracks container openings), and self-reported adherence (ability, frequency, and percent missed doses). Healthy, HIV-negative, nonpregnant US women aged 23 to 45 years received a Wisebag and 32 applicators filled with placebo gel were instructed to insert 1 applicator daily for 30 days, returned the Wisebag and all applicators, and completed an exit interview. Emptied applicators were tested by UVA and then DSA, and scored by 2 blinded readers. Positive and negative controls were randomly included in applicator batches. RESULTS: Among 42 women enrolled, 39 completed the study. Both DSA and UVA yielded similar sensitivity (97% and 95%) and specificity (79% and 79%). Two participants had fully inoperable Wisebags, and 9 had partially inoperable Wisebags. The proportion of participants considered to have high adherence (≥80%) varied: 43% (Wisebag), 46% (UVA), 49% (DSA), and 62% to 82% (self-reports). For estimating high adherence, Wisebag had a sensitivity of 76% (95% confidence interval, 50%-93%) and a specificity of 85% (95% confidence interval, 62%-97%) compared with DSA. Although 28% of participants reported forgetting to open the Wisebag daily, 59% said that it helped them remember gel use. CONCLUSIONS: Dye stain assay and UVA performed similarly. Compared with these tests, self-reports overestimated and Wisebag underestimated adherence. Although Wisebag may encourage gel use, the applicator tests currently seem more useful for measuring use in clinical trials.

Characteristics of female sex workers in southern India willing and unwilling to participate in a placebo gel trial.

Respondent-driven sampling was used to recruit female sex workers (FSWs) for a community survey conducted in southern India. After survey completion, participants were given a brochure describing a clinical trial that entailed daily use of a placebo vaginal gel for four months. This study assessed predictors of screening among survey respondents, predictors of enrollment among those eligible for the trial, and predictors of visit attendance and retention among those enrolled. FSWs who reported having symptoms of sexually transmitted infections (STI), engaging in sex work in the past month, and living in a subdistrict easily accessible by public transportation with a high concentration of FSWs, were more likely to screen. FSWs who had never been tested for HIV were more likely to enroll. This analysis suggests that the primary reason FSWs participated in the trial was a desire for health care-not other factors hypothesized to be important, e.g., HIV risk perception and poverty status.

Effect of computer-assisted interviewing on self-reported sexual behavior data in a microbicide clinical trial.

In a microbicide safety and effectiveness trial (HPTN 035) in Malawi, 585 women completed the same questionnaire through a face-to-face interview (FTFI) and an audio computer-assisted self-interview (ACASI). Concordance between FTFI and ACASI responses ranged from 72.0 % for frequency of sex in the past week to 95.2 % for anal intercourse (AI) in the past 3 months. Reported gel and condom use at last sex act were marginally lower with ACASI than FTFI (73.5 % vs. 77.2 %, p = 0.11 and 60.9 % vs. 65.5 %, p = 0.05, respectively). More women reported AI with ACASI than FTFI (5.0 % vs. 0.2 %, p < 0.001). Analyses of consistency of responses within ACASI revealed that 15.0 % of participants in the condom-only arm and 28.7 % in the gel arm provided at least one discrepant answer regarding total sex acts and sex acts where condom and gel were used (19.2 % reported one inconsistent answer, 8.1 % reported two inconsistent answers, and 1.4 % reported three inconsistent answers). While ACASI may provide more accurate assessments of sensitive behaviors in HIV prevention trials, it also results in a high level of internally inconsistent responses.

An evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, India.

Female sex workers (FSWs) were recruited for a 4-month placebo vaginal gel trial in Nellore, India. Two experiments explored if prior knowledge of biomarkers for unprotected sex and insertion of gel applicators would yield more accurate self-reports. A third experiment compared self-reports of gel use and adherence levels between FSWs randomly assigned to interactive voice response survey (IVRS) and those assigned to paper diaries. Prior knowledge of biomarkers did not improve accuracy of self-reported condom or gel use, nor did it affect actual adherence. Of those who tested positive for the presence of semenogelin in the vagina, 76% reported no unprotected sex in the previous 48 h. Overall, women reported using gel on 90% of days whereas the biomarker indicated gel use on fewer than 50% of days. Compliance to IVRS was low, despite familiarity with mobile phone technology. Additional explorations with other populations are needed.