CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 372 enrolled
Drug / intervention
1% tenofovir geldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01691768
NCT01691768Phase 3Completed
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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

Centre for the AIDS Programme of Research in South Africa·interventional·Posted Sep 25, 2012·Updated Nov 26, 2019

In Brief

A Phase 3 clinical trial evaluating 1% tenofovir gel for HIV. Completed, enrolled 372 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesSouth Africa
CollaboratorsCONRAD, Gilead Sciences, FHI 360, Institute for Healthcare Improvement

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2012
Enrollment StartOct 1, 2012
Primary CompletionApr 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.8 years ago

Interventions

1% tenofovir geldrug

Participants will be randomized to receive 1% tenofovir gel through either: * Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or * The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).