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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Centre for the AIDS Programme of Research in South Africa

Collaborator
CONRAD
Gilead Sciences
FHI 360
Institute for Healthcare Improvement

Information provided by (Responsible Party)
Dr Quarraisha Abdool Karim, Centre for the AIDS Programme of Research in South Africa

ClinicalTrials.gov Identifier
NCT01691768

First received: July 5, 2012
Last updated: January 27, 2016
Last Verified: January 2016
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV

Drug : 1% tenofovir gel
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Further study details as provided by Dr Quarraisha Abdool Karim, Centre for the AIDS Programme of Research in South Africa:

Primary Outcome Measures

  • Mean number of returned used applicators [ Time Frame: monthly ]
    Gel use is essential for the effectiveness of tenofovir gel in preventing HIV infection. The level of gel use was a strong predictor of effectiveness in the exploratory adherence analysis of the CAPRISA 004 trial. Gel use on its own and in relation to coitus were both predictors of the level of protection. Based on the CAPRISA 004 trial which demonstrated a correlation between the number of returned used applicators and the level of effectiveness against HIV infection, the primary endpoint is: • Mean number of returned used applicators per participant per month
Secondary Outcome Measures:
  • Clinical and laboratory adverse events [ Time Frame: At each participant contact ]
    Any untoward medical occurrence experienced by an enrolled research participant, regardless of association with study product, will be recorded and managed accordingly
  • HIV incidence rates [ Time Frame: at study completion ]
  • Pregnancy rates [ Time Frame: Monthly ]
  • Adherence [ Time Frame: Each scheduled study visit ]
    Self-reported adherence to the tenofovir gel dosing strategy as well as factors influencing gel use in relation to sexual activity, condom use, and intravaginal practices
  • HIV viral load among HIV seroconverters [ Time Frame: At earliest timepoint after HIV positive result ]
  • Tenofovir resistance among HIV seroconverters [ Time Frame: At study completion ]
  • HSV-2 and HPV incidence rates [ Time Frame: At study completion ]
  • Tenofovir levels [ Time Frame: At study completion ]
    Detection of tenovofir from vaginal samples
  • Product acceptability [ Time Frame: At stucy completion ]
    Self-reported questionnaire on product acceptability

Enrollment: 382
Study Start Date: October 2012
Study Completion Date: December 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Intervention
1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of QI methodology to promote reliable service delivery
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).

    Active Comparator: Control
    monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics
    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).

      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

      Eligibility

      Ages Eligible for Study: 18 Years and older  
      Sexes Eligible for Study: Female  
      Accepts Healthy Volunteers: Yes  

      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

      contacts and locations

      Contacts and Locations

      Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

      Please refer to this study by its ClinicalTrials.gov identifier: NCT01691768

      Locations

      South Africa
      CAPRISA eThekwini Clinical Research Site
      Durban, KwaZulu-Natal, South Africa, 4001
      CAPRISA Vulindlela Clinical Research Site
      Pietermaritzburg, KwaZulu-Natal, South Africa

      Sponsors and Collaborators

      Centre for the AIDS Programme of Research in South Africa
      CONRAD
      Gilead Sciences
      FHI 360
      Institute for Healthcare Improvement

      Investigators

      Principal Investigator: Quarraisha Abdool Karim, PhD Centre for the AIDS Programme of Research in South Africa
      More Information

      More Information

      Additional Information:

      Centre for the AIDS Programme of Research in South Africa web site

      Responsible Party: Dr Quarraisha Abdool Karim, Associate Scientific Director, Centre for the AIDS Programme of Research in South Africa  
      ClinicalTrials.gov Identifier: NCT01691768   History of Changes  
      Other Study ID Numbers: CAPRISA008  
      Study First Received: July 5, 2012  
      Last Updated: January 27, 2016  

      Keywords provided by Dr Quarraisha Abdool Karim, Centre for the AIDS Programme of Research in South Africa:

      microbicides
      women
      HIV prevention
      PrEP
      Tenofovir gel

      Additional relevant MeSH terms:
      Tenofovir

      ClinicalTrials.gov processed this data on October 19, 2017
      This information is provided by ClinicalTrials.gov.