{"doc_desc":{"title":"Thetha Nami ngithethe nawe (Let\u2019s Talk): Clinic Management","idno":"DDI.AHRI.PrEPImplementation.Clinical.Management","producers":[{"name":"Africa Health Research Institute","abbr":"AHRI","affiliation":"","role":""}]},"study_desc":{"title_statement":{"idno":"AHRI.PrEPImplementation.Clinical.Management","title":"Thetha Nami ngithethe nawe (Let\u2019s Talk): Clinic Management"},"authoring_entity":[{"name":"Dr Maryam,  Shahmanesh","affiliation":"Africa Health Research Institute"},{"name":"","affiliation":""},{"name":"","affiliation":""}],"oth_id":[{"name":"Jaco Dreyer","affiliation":"Africa Health Research Institute","email":"","role":"Data management, cleaning and analysis"},{"name":"Eva Ssozi","affiliation":"Africa Health Research Institute","email":"","role":"Data management, cleaning and analysis"},{"name":"","affiliation":"","email":"","role":""}],"production_statement":{"producers":[{"name":"Africa Health Research Institute","abbr":"AHRI","affiliation":"","role":""}],"funding_agencies":[{"name":"Bill and Melinda Gates foundation","abbr":"BMG","role":"Funder"}]},"version_statement":{"version":"V2.0.0"},"study_info":{"keywords":[{"keyword":"Adolescents & young adults, STI, HIV prevention, clinical management.","vocab":"Africa Health Research Institute","uri":"www.ahri.org"}],"topics":[{"topic":"Adolescents; young adults; HIV infections\/prevention & control; South Africa\/epidemiology; sexual health; PrEP; HIV prevention; clinical adherence; patient management.","vocab":"Africa Health Research Institute","uri":"www.ahri.org"}],"abstract":"Thetha Nami ngithethe nawe (Let's Talk): A stepped-wedge cluster randomised controlled trial of Social Mobilisation by peer navigators into community -based sexual health and HIV care (Including Pre-Exposure prophylaxis) to reduce sexually transmissible HIV amongst youth in rural KwaZulu-Natal, South Africa. \u201cThetha Nami ngithethe nawe\u201d intervention is a tailored psychosocial support and social mobilisation into community-based SRH and differentiated HIV prevention, including PrEP and UTT. The intervention is provided by area-based peer navigators and adolescent- and youth-friendly nurse-led SRH mobile clinics that visit fixed sites across the clusters every 2 weeks.\nPeer navigators deliver the following services to 15-30-year-olds: providing safe spaces to create an enabling environment; youth groups to mobilize young people; structured psychosocial and health needs assessment. Based on the needs assessment, they develop action plans that document the peer-led health promotion activities provided and planned. These include referral to mobile SRH and\/or other services; individualized psychosocial support, provision of condoms, HIV self-tests and\/or POCT, pregnancy tests; ART\/PrEP pick-up through serostatus neutral adherence clubs with or without HIV self-test  to support decentralised PrEP. \nMain objective\nTo identify scalable and sustainable ways to stem the HIV epidemic and its negative impact on young people aged 15-30 in rural Kwa-Zulu Natal (KZN), South Africa through effective implementation of biosocial HIV prevention.\nSpecific objectives\n1.\tTo measure the effectiveness of social mobilisation by peer navigators combined with decentralised sexual and reproductive health (SRH) services and tailored HIV prevention in\na.\tcreating demand for differentiated HIV prevention and care, and \nb.\treducing the prevalence of transmissible HIV\n2.\tTo understand real-world implementation of social mobilisation by peer navigators and decentralised SRH to deliver tailored, differentiated biosocial HIV prevention, by evaluating its acceptability, feasibility, reach, scalability and cost-effectiveness.","coll_dates":[{"start":"2022-06-06","end":"2026-02-02","cycle":""}],"nation":[{"name":"South Africa","abbreviation":"ZA"}],"geog_coverage":"Health and demographic surveillance site in the rural KwaZulu-Natal.","analysis_unit":"Adolescents and young adults aged 15-30 attending sexual and reproductive health mobile clinics in rural Kwa-Zulu Natal (KZN).","universe":"Thetha Nami ngithethe nawe is a cluster-randomized stepped-wedge trial (SWT) in 40 clusters within the health and demographic surveillance site. Clusters were randomized to receive the intervention in period 1 (early) or period 2 (delayed). Trained area-based peer navigators conducted needs assessments with youth aged 15-30 years to tailor health promotion, psychosocial support and referrals into nurse-led mobile SRH clinics.\nThe SRH mobile clinics visit the intervention clusters every 2 weeks. The clinics deliver nurse-led HIV testing, prevention and care including adolescent- and youth-friendly, gender neutral, HIV status neutral, individualized risk assessments for HIV care and PrEP, integrated with SRH services. During the SRH clinic appointment, participants receive counselling around sexual health, fertility intentions, contraception and HIV. All clinic attendees are offered pregnancy testing (if female), family planning support, choice of contraception, and syndromic management for STIs, and, if male, referral to voluntary medical male circumcision. Everyone is offered HIV counselling and POCT, and immediate initiation of ART if positive. All those who are HIV negative undergo screening for PrEP eligibility according to South African National guidelines. Those who are sexually active are also offered testing for STIs, including POCT for syphilis and hepatitis B (and vaccine if negative), self-taken vaginal swabs or urine tests for gonorrhoea and chlamydia, and treatment and partner notification if positive.","data_kind":"Survey Data"},"method":{"data_collection":{"sampling_procedure":"All young people aged 15-30 years who are residing in intervention clusters and attend one of the study clinics following informed consent\/assent.","sources":[{"name":"","origin":"","characteristics":""}],"cleaning_operations":"The data collected and captured on REDCap was uploaded to a MySQL database server within AHRI's secure server cluster."}},"data_access":{"dataset_use":{"cit_req":"Shahmanesh, M. (2026). Thetha Nami ngithethe nawe (Let\u2019s Talk): Clinic Management [Data set]. Africa Health Research Institute.\nDOI: https:\/\/doi.org\/10.23664\/AHRI.PREPIMPLEMENTATION.CLINICAL.MANAGEMENT","conditions":"The representative of the Receiving Organization agrees to comply with the following conditions:\n\n1. Access to the restricted data will be limited to the Lead Researcher and other members of the research team listed in this request.\n2. Copies of the restricted data or any data created on the basis of the original data will not be copied or made available to anyone other than those mentioned in this Data Access Agreement, unless formally authorized by the Data Archive.\n3. The data will only be processed for the stated statistical and research purpose. They will be used for solely for reporting of aggregated information, and not for investigation of specific individuals or organizations. Data will not in any way be used for any administrative, proprietary or law enforcement purposes. \n4. The Lead Researcher must state if it is their intention to match the restricted microdata with any other micro-dataset. If any matching is to take place, details must be provided of the datasets to be matched and of the reasons for the matching. Any datasets created as a result of matching will be considered to be restricted and must comply with the terms of this Data Access Agreement.\n5. The Lead Researcher undertakes that no attempt will be made to identify any individual person, family, business, enterprise or organization. If such a unique disclosure is made inadvertently, no use will be made of the identity of any person or establishment discovered and full details will be reported to the Data Archive. The identification will not be revealed to any other person not included in the Data Access Agreement.\n6. The Lead Researcher will implement security measures to prevent unauthorized access to licensed microdata acquired from the Data Archive. The microdata must be destroyed upon the completion of this research, unless the Data Archive obtains satisfactory guarantee that the data can be secured and provides written authorization to the Receiving Organization to retain them. Destruction of the microdata will be confirmed in writing by the Lead Researcher to the Data Archive.\n7. Any books, articles, conference papers, theses, dissertations, reports, or other publications that employ data obtained from the Data Archive will cite the source of data in accordance with the citation requirement provided with the dataset.\n8. An electronic copy of all reports and publications based on the requested data will be sent to the Data Archive.\n9. The original collector of the data, the Data Archive, and the relevant funding agencies bear no responsibility for use of the data or for interpretations or inferences based upon such uses.\n10. This agreement will come into force on the date that approval is given for access to the restricted dataset and remain in force until the completion date of the project or an earlier date if the project is completed ahead of time.\n11. If there are any changes to the project specification, security arrangements, personnel or organization detailed in this application form, it is the responsibility of the Lead Researcher to seek the agreement of the Data Archive to these changes. Where there is a change to the employer organization of the Lead Researcher this will involve a new application being made and termination of the original project.\n12. Breaches of the agreement will be taken seriously and the Data Archive will take action against those responsible for the lapse if willful or accidental. Failure to comply with the directions of the Data Archive will be deemed to be a major breach of the agreement and may involve recourse to legal proceedings. The Data Archive will maintain and share with partner data archives a register of those individuals and organizations which are responsible for breaching the terms of the Data Access Agreement and will impose sanctions on release of future data to these parties."}}},"schematype":"survey"}