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dc.creatorMansoor, Leila Essop.
dc.creatorAbdool Karim, Quarraisha.
dc.creatorMngadi, Kathryn Therese.
dc.creatorDlamini, Sarah Alexandra.
dc.creatorMontague, Carl.
dc.creatorNkomonde, Nelisiwe.
dc.creatorMvandaba, Nomzamo.
dc.creatorBaxter, Cheryl.
dc.creatorGengiah, Tanuja Narayansamy.
dc.creatorSamsunder, Natasha.
dc.creatorDawood, Halima.
dc.creatorGrobler, Anna Christina.
dc.creatorFröhlich, Janet Ann.
dc.creatorAbdool Karim, Salim Safurdeen.
dc.date.accessioned2016-11-08T09:57:53Z
dc.date.available2016-11-08T09:57:53Z
dc.date.created2014
dc.date.issued2014
dc.identifier.citationMansoor, L.E., Karim, Q.A., Mngadi, K.T., Dlamini, S., Montague, C., Nkomonde, N., Mvandaba, N., Baxter, C., Gengiah, T.N., Samsunder, N. and Dawood, H. Grobler, A., Frohlich, J.A., Abdool Karim. S.S. 2014. 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 15(1), 496.en_US
dc.identifier.urihttp://dx.doi.org/doi: 10.1186/1745-6215-15-496en_US
dc.identifier.urihttp://hdl.handle.net/10413/13617
dc.descriptionCAPRISA, 2014.en_US
dc.description.abstractBackground: 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.en_US
dc.language.isoenen_US
dc.publisherBioMed Central.en_US
dc.subjectSouth Africa.en_US
dc.subjectHIV prevention .en_US
dc.subjectMicrobicide.en_US
dc.subjectTenofovir gel.en_US
dc.subjectHealth systems strengthening.en_US
dc.subjectImplementation.en_US
dc.titleAssessing 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.en_US
dc.typePeer reviewed journal articleen_US


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