1,721,364 research outputs found
The preventive misconception: experiences from CAPRISA 004.
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Adherence in the CAPRISA 004 tenofovir gel microbicide trial.
Get PDFCAPRISA, 2014.High adherence is key to microbicide effectiveness. Here we provide a description of adherence
interventions and the adherence rates achieved in the CAPRISA 004 Tenofovir Gel Trial.
Adherence support for the before-and-after dosing strategy (BAT 24) was provided at enrolment
and at each monthly study visit. This initially comprised individual counselling and was replaced
midway by a structured theory-based adherence support program (ASP) based on motivational
interviewing. The 889 women were followed for an average of 18 months and attended a total of
17031 monthly visits. On average women reported 5 sex acts and returned 5.9 empty applicators
per month. The adherence rate based on applicator count in relation to all reported sex acts was
72.2% compared to the 82.0% self-reported adherence during the last sex act. Adherence support
activities, which achieve levels of adherence similar to or better than those achieved by the
CAPRISA 004 ASP, will be critical to the success of future microbicide trials
Disclosure of microbicide gel use to sexual partners: influence on adherence in the CAPRISA 004 trial.
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Establishing a cohort at high risk of HIV infection in South Africa: challenges and experiences of the CAPRISA 002 acute infection study.
Get PDFOBJECTIVES: To describe the baseline demographic data, clinical characteristics and HIV-incidence rates of a cohort at high risk for HIV infection in South Africa as well as the challenges experienced in establishing and maintaining the cohort. METHODOLOGY/PRINCIPLE FINDINGS: Between August 2004 and May 2005 a cohort of HIV-uninfected women was established for the CAPRISA 002 Acute Infection Study, a natural history study of HIV-1 subtype C infection. Volunteers were identified through peer-outreach. The cohort was followed monthly to determine HIV infection rates and clinical presentation of early HIV infection. Risk reduction counselling and male and female condoms were provided. After screening 775 individuals, a cohort of 245 uninfected high-risk women was established. HIV-prevalence at screening was 59.6% (95% CI: 55.9% to 62.8%) posing a challenge in accruing HIV-uninfected women. The majority of women (78.8%) were self-identified as sex-workers with a median of 2 clients per day. Most women (95%) reported more than one casual sexual partner in the previous 3 months (excluding clients) and 58.8% reported condom use in their last sexual encounter. Based on laboratory testing, 62.0% had a sexually transmitted infection at baseline. During 390 person-years of follow-up, 28 infections occurred yielding seroincidence rate of 7.2 (95% CI: 4.5 to 9.8) per 100 person-years. Despite the high mobility of this sex worker cohort retention rate after 2 years was 86.1%. High co-morbidity created challenges for ancillary care provision, both in terms of human and financial resources. CONCLUSIONS/SIGNIFICANCE: Challenges experienced were high baseline HIV-prevalence, lower than anticipated HIV-incidence and difficulties retaining participants. Despite challenges, we have successfully accrued this cohort of HIV-uninfected women with favourable retention, enabling us to study the natural history of HIV-1 during acute HIV-infection. Our experiences provide lessons for others establishing similar cohorts, which will be key for advancing the vaccine and prevention research agenda in resource-constrained settings
HIV disease progression in seroconvertors from the CAPRISA 004 tenofovir gel pre-exposure prophylaxis trial.
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Screening, enrollment, and pregnancy events in the CAPRISA 004 vaginal tenofovir gel trial.
No full text<p>Screening, enrollment, and pregnancy events in the CAPRISA 004 vaginal tenofovir gel trial.</p
An assessment of the likely acceptability of vaginal microbicides for HIV prevention among women in rural Ghana.
Get PDFBACKGROUND: 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
Impact of an adherence intervention on the effectiveness of tenofovir gel in the CAPRISA 004 trial.
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Measuring adherence by visual inspection of returned empty gel applicators in the CAPRISA 004 microbicide trial.
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