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

NCT01691768 | Completed Phase 2 Results DMC

• 1 other identifier: CAPRISA008
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 2

Brief 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

HIV

Keywords

microbicides; women; HIV prevention; PrEP; Tenofovir gel

Outcome Measures

Primary Outcomes (1)

• Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)

  The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for \>120 days.

  Between 2012 to 2015, up to 28 months

Secondary Outcomes (8)

• HIV Incidence Rates

  Between 2012 and 2015, up to 28 months

• Pregnancy Incidence Rates

  Between 2012 and 2015, up to 28 months

• Percentage of Participants Achieving Adherence >80%.

  Between 2012 and 2015, up to 28 months

• HIV Viral Load Among HIV Seroconverters

  Between 2012 and 2015, up to 28 months

• Tenofovir Resistance Among HIV Seroconverters

  Between 2012 and 2015, up to 28 months

Study Arms (2)

Intervention

EXPERIMENTAL

1% tenofovir gel provision through a public sector family planning services with 2-3 monthly provision and monitoring and the use of Quality Improvement methodology to promote reliable service delivery

Drug: 1% tenofovir gel

Control

ACTIVE COMPARATOR

monthly 1% tenofovir gel provision and monitoring through CAPRISA research clinics

Drug: 1% tenofovir gel

Interventions

1% tenofovir gel DRUG

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).

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal, 4001, South Africa

Location

CAPRISA Vulindlela Clinical Research Site

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Related Publications (3)

• 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. doi: 10.1126/science.1193748. Epub 2010 Jul 19.

  PMID: 20643915 BACKGROUND

• Mngadi KT, Singh JA, Mansoor LE, Wassenaar DR. Undue inducement: a case study in CAPRISA 008. J Med Ethics. 2017 Dec;43(12):824-828. doi: 10.1136/medethics-2016-103414. Epub 2017 Mar 27.

  PMID: 28348164 DERIVED

• Mansoor LE, Abdool Karim Q, Mngadi KT, Dlamini S, Montague C, Nkomonde N, Mvandaba N, Baxter C, Gengiah TN, Samsunder N, Dawood H, Grobler A, Frohlich JA, Abdool Karim SS. Assessing the implementation effectiveness and safety of 1% tenofovir gel provision through family planning services in KwaZulu-Natal, South Africa: study protocol for an open-label randomized controlled trial. Trials. 2014 Dec 19;15:496. doi: 10.1186/1745-6215-15-496.

  PMID: 25527071 DERIVED

Related Links

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

Limitations and Caveats

The 2-3 monthly intervals between clinic appointments in the control arm is likely to introduce recall bias in this arm, unlike the monthly intervals in the intervention arm.

Results Point of Contact

• Title: Nonhlanhla Yende-Zuma
• Organization: CAPRISA

nonhlanhla.yende@caprisa.org

+27 31 260 4392

Study Officials

• Quarraisha Abdool Karim, PhD

  Centre for the AIDS Programme of Research in South Africa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientific Director

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: September 25, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 26, 2019
• Results First Posted: November 26, 2019

Record last verified: 2019-11

Locations

ZA (2)