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

NCT01691768 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2019-11-26

Study results available
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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.

Conditions

Interventions

DRUG

1% tenofovir gel

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).

Sponsors & Collaborators

  • CONRAD

    collaborator OTHER

  • Gilead Sciences

    collaborator INDUSTRY

  • FHI 360

    collaborator OTHER

  • Institute for Healthcare Improvement

    collaborator OTHER

  • Centre for the AIDS Programme of Research in South Africa

    lead NETWORK

Principal Investigators

  • Quarraisha Abdool Karim, PhD · Centre for the AIDS Programme of Research in South Africa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-04-30
Completion
2015-12-31

Countries

  • South Africa

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01691768 on ClinicalTrials.gov