Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial.

Background: Female-initiated HIV-prevention options, such as microbicides, are urgently needed. We assessed Carraguard, a carrageenan-based compound developed by the Population Council, for its efficacy and long-term safety in prevention of HIV infection in women.

Methods: We undertook a randomised, placebo-controlled, double-blind trial in three South African sites in sexually-active, HIV-negative women, aged 16 years and older.

Many vaginal microbicide trial participants acknowledged they had misreported sensitive sexual behavior in face-to-face interviews.

Objective: We investigated whether participants in a phase II randomized clinical trial of a candidate vaginal microbicide ever intentionally misled interviewers.

Study Design And Setting: We used audio computer-assisted self-interviews (ACASI) to ask the South African women (n=132) participating in the trial about the accuracy of self-reported data collected during face-to-face interviews. The trial protocol recommended that women use their assigned gel (active microbicide or placebo) with condoms during each vaginal sex act.

Phase III microbicide trial methodology: opinions of experienced expanded safety trial participants in South Africa.

In preparation for effectiveness trials of candidate vaginal microbicides, scientists are debating trial design and implementation challenges, including choice of control arm(s), product-sharing across arms, and visit schedules. This study involved a survey of South African women participating in an expanded safety trial of the candidate microbicide Carraguard gel. The first 100 consenting women who attended the study clinics in Ga-Rankuwa and Gugulethu (total N = 200) were interviewed; all women had been using a study gel for at least 6 months at the time of the interview.

Agreement between self- and clinician-collected specimen results for detection and typing of high-risk human papillomavirus in specimens from women in Gugulethu, South Africa.

We assessed the agreement in detection of high-risk human papillomavirus (HPV), as well as specific HPV types, between self- and clinician-obtained specimens for 450 women over 18 years of age attending a community health center in Gugulethu, South Africa. Both self-collected swabs and tampons had high agreement with clinician-obtained brushes when the Roche Reverse Line Blot Assay (RLBA) was used (for swabs, 86% concordance, with a kappa statistic [kappa] of 0.71; for tampons, 89% concordance, with kappa of 0.

Two methods of self-sampling compared to clinician sampling to detect reproductive tract infections in Gugulethu, South Africa.

Objectives: To assess the validity, feasibility, and acceptability of 2 methods of self-sampling compared to clinician sampling during a speculum examination.

Goal: To improve screening for reproductive tract infections (RTIs) in resource-poor settings.

Study Design: In a public clinic in Cape Town, 450 women underwent a speculum examination and were randomized to self-sample with either a tampon or vaginal swabs.