Clinical trial NCT01691768: Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV
Keywords: microbicides
women
HIV prevention
PrEP
Tenofovir gel
Lead sponsor: Centre for the AIDS Programme of Research in South Africa
Sponsor class: NETWORK
Collaborators: name: CONRAD
name: Gilead Sciences
name: FHI 360
name: Institute for Healthcare Improvement
First posted: 2012-09-25
Enrollment: 372
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)
timeFrame: Between 2012 to 2015, up to 28 months
Secondary outcomes:
measure: HIV Incidence Rates
timeFrame: Between 2012 and 2015, up to 28 months
measure: Pregnancy Incidence Rates
timeFrame: Between 2012 and 2015, up to 28 months
measure: Percentage of Participants Achieving Adherence >80%.
timeFrame: Between 2012 and 2015, up to 28 months
measure: HIV Viral Load Among HIV Seroconverters
timeFrame: Between 2012 and 2015, up to 28 months
measure: Tenofovir Resistance Among HIV Seroconverters
timeFrame: Between 2012 and 2015, up to 28 months
measure: Human Papillomavirus Incidence Rates
timeFrame: Between 2012 and 2015, up to 28 months
measure: Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up
timeFrame: All participants with drug levels at 12 months of follow-up
measure: Product Acceptability
timeFrame: At study completion, up to 28 months
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: CAPRISA eThekwini Clinical Research Site
state: KwaZulu-Natal
city: Pietermaritzburg
country: South Africa
facility: CAPRISA Vulindlela Clinical Research Site
state: KwaZulu-Natal
Study officials:
affiliation: Centre for the AIDS Programme of Research in South Africa
name: Quarraisha Abdool Karim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19.
citation: Mngadi KT, Singh JA, Mansoor LE, Wassenaar DR. Undue inducement: a case study in CAPRISA 008. J Med Ethics. 2017 Dec;43(12):824-828. doi: 10.1136/medethics-2016-103414. Epub 2017 Mar 27.
citation: Mansoor LE, Abdool Karim Q, Mngadi KT, Dlamini S, Montague C, Nkomonde N, Mvandaba N, Baxter C, Gengiah TN, Samsunder N, Dawood H, Grobler A, Frohlich JA, Abdool Karim SS. Assessing the implementation effectiveness and safety of 1% tenofovir gel provision through family planning services in KwaZulu-Natal, South Africa: study protocol for an open-label randomized controlled trial. Trials. 2014 Dec 19;15:496. doi: 10.1186/1745-6215-15-496.