Measuring adherence by visual inspection of returned empty gel applicators in the CAPRISA 004 microbicide trial.

CAPRISA, 2014.Abstract not available in pdf

HIV-positive status disclosure in patients in care in rural South Africa: implications for scaling up treatment and prevention interventions.

CAPRISA, 2015Abstract available in pdf

Social context of adherence in an open-label 1% tenofovir gel trial : gender dynamics and disclosure in KwaZulu-Natal, South Africa.

CAPRISA, 2016.Abstract available in PDF file

Impact of an adherence intervention on the effectiveness of tenofovir gel in the CAPRISA 004 trial.

CAPRISA, 2014.Abstract not available in pdf

High mortality rates in men initiated on anti-retroviral treatment in KwaZulu-Natal, South Africa.

CAPRISA, 2017.Abstract available in pdf

Genital inflammation undermines the effectiveness of tenofovir gel in preventing HIV acquisition in women.

CAPRISA, 2018.Abstract available in pdf

High burden of human papillomavirus (HPV) infection among young women in KwaZulu-Natal, South Africa.

CAPRISA, 2016.Abstract available in PDF file

Women with pregnancies had lower adherence to 1% Tenofovir vaginal gel as HIV preexposure prophylaxis in CAPRISA 004, a phase IIB randomized-controlled trial.

Background: Antiretroviral prophylaxis may be a critical strategy to reduce periconception HIV transmission. Maximizing the benefit of periconception pharmacologic HIV risk-reduction requires an understanding of the links between pregnancy and adherence to this prevention strategy. Methods: We assessed study gel adherence among women with pregnancies compared to women without pregnancies enrolled in the CAPRISA 004 phase IIB trial of 1% vaginal tenofovir gel. Pregnancy was assessed with monthly urine tests. Adherence was measured monthly and defined as proportion of sex acts covered by two returned, used applicators based on pre- and post-coital dosing. High adherence was defined as a median adherence score of >80%, that is, more than 80% of sex acts were covered by two applications of study gel. A multivariate generalized estimating equations (GEE) model with a binomial distribution was used to assess covariates associated with high adherence (>80%) over time. Median adherence before and after pregnancy was compared using Wilcoxon signed rank test. Results: Among 868 women, 53 had at least 1 pregnancy (4.06 per 100 woman years, 95% CI: 3.04, 5.31). Women with pregnancies had lower median adherence compared to women without pregnancies (50% [IQR: 45–83] vs. 60% [IQR: 50–100], p = 0.02). Women with pregnancies also had a 48% lower odds of high adherence compared to women without pregnancies when adjusting for confounders (aOR 0.52, 95%CI: 0.41–0.66, p<0.0001). Among women with pregnancies, adherence before and after pregnancy was not different (50% [IQR: 46–83] vs. 55% [IQR: 20–100], p = 0.68). Conclusions: Women with pregnancies were less likely to have high adherence to study gel compared to women without pregnancies. Understanding these differences may inform findings from HIV prevention trials and future implementation of antiretroviral prophylaxis for at-risk women who choose to conceive. The protocol for the parent trial is registered on ClinicalTrials.gov, NCT00441298, http://www.clinicaltrials.gov/ct2/show/NCT00441298

An assessment of the likely acceptability of vaginal microbicides for HIV prevention among women in rural Ghana.

BACKGROUND: The findings of the CAPRISA tenofovir studies have raised expectations that soon an approved microbicide would be available. However it is in only a limited number of countries in sub-Saharan Africa that the acceptability of microbicides has been evaluated. We conducted a study to assess the acceptability of vaginal microbicides among women in rural Ghana. METHODS: The study employs a mixed method design, using cross-sectional survey and focus group discussions to further understand issues related to awareness and attitudes towards microbicide development, acceptability and perceived partner attitudes among pregnant women attending antenatal clinic in two health facilities in the Kintampo North municipality of Ghana. We used logistic regression to identify possible predictors of microbicide acceptability among the women surveyed. RESULTS: Although only 2% of the 504 women were aware of the development of microbicides, 95% were willing to use one when it became available. The cost of a microbicide that will be considered affordable to 50% of women was US$0.75. Although there were concerns about possible wetting effect, gel or creams were the most preferred (68% of women) formulation. Although 71% thought their partners will find microbicide acceptable, apprehensions about the feasibility of and consequences of failed discreet use were evident. 49% of women were concerned about possible negative effect of microbicide on sexual pleasure. Perceived partner acceptability (O.R. =17.7; 95%C.I. 5.03-62.5) and possibility of discreet use (O.R. =8.9 95%C.I. 2.63-30.13) were the important predictors of microbicide acceptability. CONCLUSION: Achieving microbicide acceptability among male partners should be made a part of the promotive interventions for ensuring effective use among women in rural Ghana