Open-Label Randomized Controlled Trial to Assess the Implementation Effectiveness and Safety of 1% Tenofovir Gel Provision Through Family Planning Services in KwaZulu-Natal, South Africa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)
研究概览
简要总结
The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.
详细描述
The CAPRISA 008 trial is a two-arm, open-label, randomized controlled trial that is being conducted at the CAPRISA eThekwini and CAPRISA Vulindlela Clinics and their neighboring public sector family planning services in KwaZulu-Natal, South Africa. Up to 700 consenting sexually active, HIV-uninfected women aged 18 years and older who previously participated in an antiretroviral (ARV) prevention study will be enrolled and followed for a maximum 30 months. All women will be provided with 1% tenofovir gel but will be randomised to either receive their gel through a public sector family planning services with 2-3 monthly provision (intervention arm) or through the CAPRISA research clinics with monthly provision (control arm).
All women in the trial will be provided with the standard package of HIV prevention and reproductive health services. Participants in both study arms will be provided with a supply of single-use, pre-filled applicators of 1% tenofovir gel. While in the study, participants will be advised and supported to follow the CAPRISA 004 pre- and post-dosing strategy, namely BAT24, where the first dose of tenofovir gel is applied within 12 hours before anticipated coitus and a second dose as soon as possible but within 12 hours after coitus, with a maximum of two doses of gel in a 24-hour period.
The primary objective of this trial is to assess the effectiveness of an implementation model for tenofovir gel provision through family planning services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years and older
- •Women who previously participated in an ARV prevention study
- •Currently utilizing or agreeing to attend designated public sector family planning services
- •Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
- •Able and willing to provide adequate locator information for study retention purposes
- •Sexually active (at least one coital act in the last 3 months prior to screening)
- •HIV negative (by HIV testing performed by study staff within 30 days of enrollment)
- •Negative pregnancy test performed by study staff within 21 days of enrollment
- •Agree to use a non-barrier form of contraceptive
- •Agree to adhere to study visits and procedures
排除标准
- •Has a creatinine clearance < 50ml/min
- •Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
研究组 & 干预措施
Intervention
1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery
干预措施: 1% tenofovir gel (Drug)
Control
monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics
干预措施: 1% tenofovir gel (Drug)
结局指标
主要结局
Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)
时间窗: Between 2012 to 2015, up to 28 months
The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for \>120 days.
次要结局
- Percentage of Participants Achieving Adherence >80%.(Between 2012 and 2015, up to 28 months)
- HIV Viral Load Among HIV Seroconverters(Between 2012 and 2015, up to 28 months)
- Tenofovir Resistance Among HIV Seroconverters(Between 2012 and 2015, up to 28 months)
- HIV Incidence Rates(Between 2012 and 2015, up to 28 months)
- Pregnancy Incidence Rates(Between 2012 and 2015, up to 28 months)
- Human Papillomavirus Incidence Rates(Between 2012 and 2015, up to 28 months)
- Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up(All participants with drug levels at 12 months of follow-up)
- Product Acceptability(At study completion, up to 28 months)
研究者
Dr Quarraisha Abdool Karim
Associate Scientific Director
Centre for the AIDS Programme of Research in South Africa