title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  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.
authors.affiliation: Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa. Leila.Mansoor@caprisa.org.
authors.forename: Leila E
authors.initials: LE
authors.lastname: Mansoor
authors.forename: Quarraisha
authors.initials: Q
authors.lastname: Abdool Karim
authors.forename: Kathryn T
authors.initials: KT
authors.lastname: Mngadi
authors.forename: Sarah
authors.initials: S
authors.lastname: Dlamini
authors.forename: Carl
authors.initials: C
authors.lastname: Montague
authors.forename: Nelisiwe
authors.initials: N
authors.lastname: Nkomonde
authors.forename: Nomzamo
authors.initials: N
authors.lastname: Mvandaba
authors.forename: Cheryl
authors.initials: C
authors.lastname: Baxter
authors.forename: Tanuja N
authors.initials: TN
authors.lastname: Gengiah
authors.forename: Natasha
authors.initials: N
authors.lastname: Samsunder
authors.forename: Halima
authors.initials: H
authors.lastname: Dawood
authors.forename: Anneke
authors.initials: A
authors.lastname: Grobler
authors.forename: Janet A
authors.initials: JA
authors.lastname: Frohlich
authors.forename: Salim S
authors.initials: SS
authors.lastname: Abdool Karim
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D005193:Family Planning Services / Q000592:standards; D005260:Female; D005782:Gels; D015658:HIV Infections / Q000175:diagnosis / Q000517:prevention & control* / Q000635:transmission; D006297:Health Services Accessibility / Q000592:standards; D006801:Humans; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D015397:Program Evaluation; D058996:Quality Improvement; D019984:Quality Indicators, Health Care; D012107:Research Design; D019035:Rural Health Services / Q000592:standards; D013019:South Africa; D000068698:Tenofovir; D013997:Time Factors; D016896:Treatment Outcome; D019037:Urban Health Services / Q000592:standards; D014932:Women's Health Services / Q000592:standards; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D005782:Gels; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine