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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

July 5, 2012
April 23, 2013
October 2012
March 2015   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01691768 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services
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

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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
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).
  • 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
    Intervention: Drug: 1% tenofovir gel
  • Active Comparator: Control
    monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics
    Intervention: Drug: 1% tenofovir gel
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. Epub 2010 Jul 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
700
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Leila E Mansoor, PhD +2731 260 4641 mansoor@ukzn.ac.za
Contact: Jennifer David +27312604076 davidj@ukzn.ac.za
South Africa
 
NCT01691768
CAPRISA008
Yes
Dr Quarraisha Abdool Karim, Centre for the AIDS Programme of Research in South Africa
Centre for the AIDS Programme of Research in South Africa
  • CONRAD
  • Gilead Sciences
  • FHI 360
  • Institute for Health Care Improvement
Principal Investigator: Quarraisha Abdool Karim, PhD Centre for the AIDS Programme of Research in South Africa
Centre for the AIDS Programme of Research in South Africa
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP