Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial

Introduction Young women are disproportionately affected by HIV in South Africa and have a high incidence of unintended pregnancies. Access to sexual and reproductive health (SRH) services, including HIV pre-exposure prophylaxis (PrEP), contraception and screening for seally transmitted infections (...

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Main Authors: Christina Psaros, Ingrid Bassett, Sabina Medal Govere, Jana Jarolimova, Joyce Yan, Sthabile Shezi, Lungile M Ngcobo, Shruti Sagar, Dani Zionts, Nduduzo Dube, RA Parker
Format: Article
Language:English
Published: BMJ Publishing Group 2024-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/12/e083621.full
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author Christina Psaros
Ingrid Bassett
Sabina Medal Govere
Jana Jarolimova
Joyce Yan
Sthabile Shezi
Lungile M Ngcobo
Shruti Sagar
Dani Zionts
Nduduzo Dube
RA Parker
author_facet Christina Psaros
Ingrid Bassett
Sabina Medal Govere
Jana Jarolimova
Joyce Yan
Sthabile Shezi
Lungile M Ngcobo
Shruti Sagar
Dani Zionts
Nduduzo Dube
RA Parker
author_sort Christina Psaros
collection DOAJ
description Introduction Young women are disproportionately affected by HIV in South Africa and have a high incidence of unintended pregnancies. Access to sexual and reproductive health (SRH) services, including HIV pre-exposure prophylaxis (PrEP), contraception and screening for seally transmitted infections (STIs), remains limited in South Africa, in part due to inadequate infrastructure and individual barriers to care. Integrated, community-based SRH services have the potential to overcome barriers to clinic-based care for women at risk of HIV, unintended pregnancy and STIs. We are evaluating the feasibility, acceptability and preliminary effectiveness of a novel intervention offering PrEP, contraception and STI screening in hair salons.Methods and analysis We will conduct a pilot cluster randomised controlled trial in hair salons in urban KwaZulu-Natal, South Africa. Salons serving primarily female clients will be randomised either to an SRH service package (offer of PrEP, contraception, STI screening and health education) or to health education only. Interested female salon clients≥18 years old will be referred by trained stylists. In intervention salons, women who meet inclusion criteria will be offered HIV and pregnancy testing; if eligible, they will be offered oral PrEP, contraception (oral or injectable) and STI screening. Follow-up visits including monitoring side effects will be conducted at baseline and 3, 6, 9 and 12 months. We will measure intervention uptake as the proportion of eligible women who agree to salon-based PrEP and separately to salon-based contraception. We will assess feasibility by collecting process measures and evaluate retention as continued use of PrEP and contraception separately, defined as one additional visit within 6 months with continued use of PrEP and/or contraception.Ethics and dissemination The study has been approved by the University of KwaZulu-Natal Biomedical Research Ethics Committee and the Massachusetts General Brigham Institutional Review Board. The results will be disseminated to local and provincial Departments of Health, at scientific conferences and in peer-reviewed scientific journals.Trial registration number NCT04222504. Registered January 2020.
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spelling doaj-art-ff64cd3f2c794322ba127e25bd919f8f2025-01-14T11:20:09ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2023-083621Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trialChristina Psaros0Ingrid Bassett1Sabina Medal Govere2Jana Jarolimova3Joyce Yan4Sthabile Shezi5Lungile M Ngcobo6Shruti Sagar7Dani Zionts8Nduduzo Dube9RA Parker106 Harvard University Center for AIDS Research, Boston, Massachusetts, USA2 Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA1 AIDS Healthcare Foundation, Durban, KwaZulu Natal, South Africa3 Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA5 Biostatistics Center, Massachusetts General Hospital, Boston, Massachusetts, USA1 AIDS Healthcare Foundation, Durban, KwaZulu Natal, South Africa1 AIDS Healthcare Foundation, Durban, KwaZulu Natal, South Africa2 Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA2 Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA1 AIDS Healthcare Foundation, Durban, KwaZulu Natal, South Africa4 Harvard Medical School, Boston, Massachusetts, USAIntroduction Young women are disproportionately affected by HIV in South Africa and have a high incidence of unintended pregnancies. Access to sexual and reproductive health (SRH) services, including HIV pre-exposure prophylaxis (PrEP), contraception and screening for seally transmitted infections (STIs), remains limited in South Africa, in part due to inadequate infrastructure and individual barriers to care. Integrated, community-based SRH services have the potential to overcome barriers to clinic-based care for women at risk of HIV, unintended pregnancy and STIs. We are evaluating the feasibility, acceptability and preliminary effectiveness of a novel intervention offering PrEP, contraception and STI screening in hair salons.Methods and analysis We will conduct a pilot cluster randomised controlled trial in hair salons in urban KwaZulu-Natal, South Africa. Salons serving primarily female clients will be randomised either to an SRH service package (offer of PrEP, contraception, STI screening and health education) or to health education only. Interested female salon clients≥18 years old will be referred by trained stylists. In intervention salons, women who meet inclusion criteria will be offered HIV and pregnancy testing; if eligible, they will be offered oral PrEP, contraception (oral or injectable) and STI screening. Follow-up visits including monitoring side effects will be conducted at baseline and 3, 6, 9 and 12 months. We will measure intervention uptake as the proportion of eligible women who agree to salon-based PrEP and separately to salon-based contraception. We will assess feasibility by collecting process measures and evaluate retention as continued use of PrEP and contraception separately, defined as one additional visit within 6 months with continued use of PrEP and/or contraception.Ethics and dissemination The study has been approved by the University of KwaZulu-Natal Biomedical Research Ethics Committee and the Massachusetts General Brigham Institutional Review Board. The results will be disseminated to local and provincial Departments of Health, at scientific conferences and in peer-reviewed scientific journals.Trial registration number NCT04222504. Registered January 2020.https://bmjopen.bmj.com/content/14/12/e083621.full
spellingShingle Christina Psaros
Ingrid Bassett
Sabina Medal Govere
Jana Jarolimova
Joyce Yan
Sthabile Shezi
Lungile M Ngcobo
Shruti Sagar
Dani Zionts
Nduduzo Dube
RA Parker
Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial
BMJ Open
title Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial
title_full Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial
title_fullStr Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial
title_full_unstemmed Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial
title_short Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial
title_sort uptake of hiv pre exposure prophylaxis and contraception in south african hair salons a study protocol for a pilot cluster randomised controlled trial
url https://bmjopen.bmj.com/content/14/12/e083621.full
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