Browsing by Author "Montague, Carl."
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Item 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.(BioMed Central., 2014) Mansoor, Leila Essop.; Abdool Karim, Quarraisha.; Mngadi, Kathryn Therese.; Dlamini, Sarah Alexandra.; Montague, Carl.; Nkomonde, Nelisiwe.; Mvandaba, Nomzamo.; Baxter, Cheryl.; Gengiah, Tanuja Narayansamy.; Samsunder, Natasha.; Dawood, Halima.; Grobler, Anna Christina.; Fröhlich, Janet Ann.; Abdool Karim, Salim Safurdeen.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.Item Early resumption of sex following voluntary medical male circumcision amongst school-going males.(Public Library of Science., 2016) George, Gavin Lloyd.; Govender, Kaymarlin.; Beckett, Sean.; Montague, Carl.; Fröhlich, Janet Ann.Abstract available in pdf.Item Factors associated with the take-up of voluntary medical male circumcision amongst learners in rural KwaZulu-Natal.(National Inquiry Services Centre., 2017) George, Gavin Lloyd.; Govender, Kaymarlin.; Beckett, Sean.; Montague, Carl.; Fröhlich, Janet Ann.Abstract available in pdf.Item Implementation of adolescent-friendly voluntary medical male circumcision using a school based recruitment program in rural KwaZulu-Natal, South Africa.(Public Library of Science., 2014) Montague, Carl.; Ngcobo, Nelisiwe.; Mahlase, Gethwana.; Fröhlich, Janet Ann.; Pillay, Cheryl.; Yende-Zuma, Fortunate Nonhlanhla.; Humphries, Hilton Richard.; Dellar, Rachael Claire.; Naidoo, Kogieleum.; Abdool Karim, Quarraisha.Background: Epidemiological data from South Africa demonstrate that risk of human immunodeficiency virus (HIV) infection in males increases dramatically after adolescence. Targeting adolescent HIV-negative males may be an efficient and cost-effective means of maximising the established HIV prevention benefits of voluntary medical male circumcision (VMMC) in high HIV prevalence-, low circumcision practice-settings. This study assessed the feasibility of recruiting male high school students for VMMC in such a setting in rural KwaZulu-Natal. Methods and Findings: Following community and key stakeholder consultations on the acceptability of VMMC recruitment through schools, information and awareness raising sessions were held in 42 high schools in Vulindlela. A three-phase VMMC demand-creation strategy was implemented in partnership with a local non-governmental organization, ZimnadiZonke, that involved: (i) community consultation and engagement; (ii) in-school VMMC awareness sessions and centralized HIV counselling and testing (HCT) service access; and (iii) peer recruitment and decentralized HCT service access. Transport was provided for volunteers to the Centre for the AIDS Programme of Research in South Africa (CAPRISA) clinic where the forceps-guided VMMC procedure was performed on consenting HIV-negative males. HIV infected volunteers were referred to further care either at the CAPRISA clinic or at public sector clinics. Between March 2011 and February 2013, a total of 5165 circumcisions were performed, the majority (71%) in males aged between 15 and 19 years. Demand-creation strategies were associated with an over five-fold increase in VMMC uptake from an average of 58 procedures/month in initial community engagement phases, to an average of 308 procedures/month on initiation of the peer recruitment-decentralized service phase. Post-operative adverse events were rare (1.2%), mostly minor and self-resolving. Conclusions: Optimizing a high volume, adolescent-targeted VMMC program was feasible, acceptable and safe in this setting. Adaptive demand-creation strategies are required to sustain high uptake.Item Meeting the sexual and reproductive health needs of high-school students in South Africa: experiences from rural KwaZulu-Natal.(South African Medical Association., 2014) Fröhlich, Janet Ann.; Mkhize, Nolunthando.; Dellar, Rachael Claire.; Mahlase, Gethwana.; Montague, Carl.; Abdool Karim, Quarraisha.Abstract available in pdf.