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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Centre for the AIDS Programme of Research in South Africa
Sponsor:
Collaborators:
CONRAD
Gilead Sciences
FHI 360
Institute for Health Care 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: April 23, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre for the AIDS Programme of Research in South Africa:

Primary Outcome Measures:
  • Mean number of returned used applicators [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Pregnancy rates [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
  • Adherence [ Time Frame: Each scheduled study visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Tenofovir resistance among HIV seroconverters [ Time Frame: At study completion ] [ Designated as safety issue: Yes ]
  • HSV-2 and HPV incidence rates [ Time Frame: At study completion ] [ Designated as safety issue: Yes ]
  • Tenofovir levels [ Time Frame: At study completion ] [ Designated as safety issue: Yes ]
    Detection of tenovofir from vaginal samples

  • Product acceptability [ Time Frame: At stucy completion ] [ Designated as safety issue: No ]
    Self-reported questionnaire on product acceptability


Estimated Enrollment: 700
Study Start Date: October 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders 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
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

Contacts
Contact: Leila E Mansoor, PhD +2731 260 4641 mansoor@ukzn.ac.za
Contact: Jennifer David +27312604076 davidj@ukzn.ac.za

Locations
South Africa
CAPRISA eThekwini Clinical Research Site Recruiting
Durban, KwaZulu-Natal, South Africa, 4001
Contact: Kathy Mngadi, MBChB    +27312604125    mngadik@ukzn.ac.za   
Contact: Nomzamo Mvandaba    +27312601971    Mvandaba@ukzn.ac.za   
Sub-Investigator: Gonasagrie Nair, MBChB         
Sub-Investigator: Nivashnee Naicker, MBChB         
Sub-Investigator: Nigel Garrett, MD         
CAPRISA Vulindlela Clinical Research Site Recruiting
Pietermaritzburg, KwaZulu-Natal, South Africa
Contact: Carl Montague, PhD    +27332606851      
Contact: Nelisiwe Nkomonde, Hons (Psych)    +27332606891    nkomonde@ukzn.ac.za   
Sub-Investigator: Halima Dawood, MBChB         
Sub-Investigator: Katherine York, MBChB         
Sub-Investigator: Sarah Dlamini, MBChB         
Sponsors and Collaborators
Centre for the AIDS Programme of Research in South Africa
CONRAD
Gilead Sciences
FHI 360
Institute for Health Care Improvement
Investigators
Principal Investigator: Quarraisha Abdool Karim, PhD Centre for the AIDS Programme of Research in South Africa
  More Information

Publications:
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
Obsolete Identifiers: NCT01645813
Other Study ID Numbers: CAPRISA008
Study First Received: July 5, 2012
Last Updated: April 23, 2013
Health Authority: South Africa: Medicines Control Council

Keywords provided by Centre for the AIDS Programme of Research in South Africa:
microbicides
women
HIV prevention
PrEP
Tenofovir gel

Additional relevant MeSH terms:
Anti-Infective Agents
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 29, 2014