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

Autor: Janet A. Frohlich, Leila E. Mansoor, Halima Dawood, Kathryn Therese. Mngadi, Nomzamo. Mvandaba, Sarah. Dlamini, Natasha Samsunder, C. T. Montague, Cheryl Baxter, Quarraisha Abdool Karim, Salim S. Abdool Karim, Nelisiwe Nkomonde, Anna Christina. Grobler, Tanuja N. Gengiah
Jazyk: angličtina
Rok vydání: 2014
Předmět:
Program evaluation
Time Factors
Medicine (miscellaneous)
HIV Infections
Health Services Accessibility
law.invention
Study Protocol
South Africa
Randomized controlled trial
Clinical Protocols
immune system diseases
law
Interim
Urban Health Services
Medicine
Pharmacology (medical)
virus diseases
16. Peace & justice
Quality Improvement
3. Good health
Women's Health Services
Treatment Outcome
Research Design
Family Planning Services
Female
Adult
Adolescent
Anti-HIV Agents
HIV prevention
Organophosphonates
Microbicide
Confirmatory trial
Tenofovir gel
Young Adult
Acquired immunodeficiency syndrome (AIDS)
Nursing
CAPRISA 004
Humans
Health systems strengthening
Tenofovir
Quality Indicators
Health Care
Window of opportunity
business.industry
Adenine
medicine.disease
Microbicides for sexually transmitted diseases
Implementation
Rural Health Services
business
Gels
Program Evaluation
Zdroj: Trials
ISSN: 1745-6215
Popis: Background The Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial demonstrated a 39% reduction in HIV infection, with a 54% HIV reduction in women who used tenofovir gel consistently. A confirmatory trial is expected to report results in early 2015. In the interim, we have a unique window of opportunity to prepare for and devise effective strategies for the future policy and programmatic scale-up of tenofovir gel provision. One approach is to integrate tenofovir gel provision into family planning (FP) services. The CAPRISA 008 implementation trial provides an opportunity to provide post-trial access to tenofovir gel while generating empiric evidence to assess whether integrating tenofovir gel provision into routine FP services can achieve similar levels of adherence as the CAPRISA 004 trial. Methods/design This is a two-arm, open-label, randomized controlled non-inferiority trial. A maximum of 700 sexually active, HIV-uninfected women aged 18 years and older who previously participated in an antiretroviral prevention study will be enrolled from an urban and rural site in KwaZulu-Natal, South Africa. The anticipated study duration is 30 months, with active accrual requiring approximately 12 months (following which an open cohort will be maintained) and follow-up continuing for approximately 18 months. At each of the two sites, eligible participants will be randomly assigned to receive tenofovir gel through either FP services (intervention arm) or through the CAPRISA research clinics (control arm). As part of the study intervention, a quality improvement approach will be used to assist the FP services to expand their current services to include tenofovir gel provision. Discussion This protocol aims to address an important implementation question on whether FP services are able to effectively incorporate tenofovir gel provision for this at-risk group of women in South Africa. Provision of tenofovir gel to the women from the CAPRISA 004 trial meets the ethical obligation for post-trial access, and helps identify a potential avenue for future scale-up of microbicides within the public health system of South Africa. Trial registration This trial was registered with the South Africa Department of Health (reference: DOH-27-0812-4129) and ClinicalTrials.gov (reference: NCT01691768) on 05 July 2012.
Databáze: OpenAIRE
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