Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services

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

The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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