Dataset Information

Regulation of HIV self-testing in Malawi, Zambia and Zimbabwe: a qualitative study with key stakeholders.

ABSTRACT: INTRODUCTION:HIV self-testing (HIVST) is being introduced as a new way for more undiagnosed people to know their HIV status. As countries start to implement HIVST, assuring the quality and regulating in vitro diagnostics, including HIVST, are essential. We aimed to document the emerging regulatory landscape and perceptions of key stakeholders involved in HIVST policy and regulation prior to implementation in three low- and middle-income countries. METHODS:Between April and August 2016, we conducted semi-structured interviews in Malawi, Zambia and Zimbabwe to understand the relationships between different stakeholders on their perceptions of current and future HIVST regulation and the potential impact on implementation. We purposively sampled and interviewed 66 national-level key stakeholders from the Ministry of Health and the regulatory, laboratory, logistical, donor and non-governmental sectors. We used a thematic approach to analysis with an inductively developed common coding framework to allow inter-country comparison of emerging themes. RESULTS:In all countries, the national reference laboratory was monitoring the quality of HIVST kits entering the public sector. In Malawi, there was no legal mandate to regulate medical devices, in Zambia one regulatory body with a clear mandate had started developing regulations and in Zimbabwe the mandate to regulate was overlapping between two bodies. Stakeholders indicated that they had a poor understanding of the process and requirements for HIVST regulation, as well as lack of clarity and coordination between organizational roles. The need for good collaboration between sectors, a strong post-market surveillance model for HIVST and technical assistance to develop regulators capacity was noted as priorities. Key informants identified technical working groups as a potential way collaboration could be improved upon to accelerate the regulation of HIVST. CONCLUSION:Regulation of in vitro diagnostic devices, including HIVST, is now being recognized as important by regulators after a regional focus on pharmaceuticals. HIVST is providing an opportunity for each country to develop similar regulations to others in the region leading to a more coherent regulatory environment for the introduction of new devices.

SUBMITTER: Dacombe RJ

PROVIDER: S-EPMC6432109 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Regulation of HIV self-testing in Malawi, Zambia and Zimbabwe: a qualitative study with key stakeholders.

Dacombe Russell J RJ Watson Victoria V Nyirenda Lot L Madanhire Claudius C Simwinga Musonda M Chepuka Lignet L Johnson Cheryl C CC Corbett Elizabeth L EL Hatzold Karin K Taegtmeyer Miriam M

Journal of the International AIDS Society 20190301

<h4>Introduction</h4>HIV self-testing (HIVST) is being introduced as a new way for more undiagnosed people to know their HIV status. As countries start to implement HIVST, assuring the quality and regulating in vitro diagnostics, including HIVST, are essential. We aimed to document the emerging regulatory landscape and perceptions of key stakeholders involved in HIVST policy and regulation prior to implementation in three low- and middle-income countries.<h4>Methods</h4>Between April and August ...[more]

PMID: 30907513

Similar Datasets

Project description:INTRODUCTION:HIV self-testing (HIVST) is recommended by the World Health Organization in addition to other testing modalities to increase uptake of HIV testing, particularly among harder-to-reach populations. This study provides the first empirical evidence of the costs of door-to-door community-based HIVST distribution in Malawi, Zambia and Zimbabwe. METHODS:HIVST kits were distributed door-to-door in 71 sites across Malawi, Zambia and Zimbabwe from June 2016 to May 2017. Programme expenditures, supplemented by on-site observation and monitoring and evaluation data were used to estimate total economic and unit costs of HIVST distribution, by input and site. Inputs were categorized into start-up, capital and recurrent costs. Sensitivity and scenario analyses were performed to assess the impact of key parameters on unit costs. RESULTS:In total, 152,671, 103,589 and 93,459 HIVST kits were distributed in Malawi, Zambia and Zimbabwe over 12, 11 and 10 months respectively. Across these countries, 43% to 51% of HIVST kits were distributed to men. The average cost per HIVST kit distributed was US$8.15, US$16.42 and US$13.84 in Malawi, Zambia and Zimbabwe, respectively, with pronounced intersite variation within countries driven largely by site-level fixed costs. Site-level recurrent costs were 70% to 92% of full costs and 20% to 62% higher than routine HIV testing services (HTS) costs. Personnel costs contributed from 26% to 52% of total costs across countries reflecting differences in remuneration approaches and country GDP. CONCLUSIONS:These early door-to-door community HIVST distribution programmes show large potential, both for reaching untested populations and for substantial economies of scale as HIVST programmes scale-up and mature. From a societal perspective, the costs of HIVST appear similar to conventional HTS, with the higher providers' costs substantially offsetting user costs. Future approaches to minimizing cost and/or maximize testing coverage could include unpaid door-to-door community-led distribution to reach end-users and integrating HIVST into routine clinical services via direct or secondary distribution strategies with lower fixed costs.

Project description:INTRODUCTION:The World Health Organisation recommends HIV self-testing as an alternative testing method to help reach underserved populations, such as men in sub-Saharan Africa. Successful implementation and scale-up of HIV self-testing (HIVST) in Rwanda relies heavily on relevant stakeholders' involvement. We sought to explore HIVST key stakeholders' perceptions of the implementation and scale-up of HIVST in Rwanda. METHOD:We conducted in-depth interviews with personnel involved in HIV response projects in Rwanda between September and November 2019. We purposively sampled and interviewed 13 national-level key stakeholders from the Ministry of Health, Rwanda Biomedical Center, non-governmental organizations and HIV clinics at tertiary health facilities in Kigali. We used a thematic approach to analysis with a coding framework guided by Consolidated Framework for Implementation Research (intervention characteristics, inner setting, outer setting, characteristics of individuals involved in the implementation and the implementation process). RESULTS:Key stakeholders perceived HIVST as a potentially effective initiative, which can be used in order to ensure that there is an improvement in uptake of testing services, especially for underserved populations in Rwanda. The following challenges for implementation and scale-up of HIVST were revealed: lack of awareness of the kits, high cost of the self-test kits, and concerns on results interpretation. Key stakeholders identified the following as prerequisites to the successful implementation and scale-up of HIVST in Rwanda; creation of awareness, training those involved in the implementation process, regulation of the selling of the self-test kits, reduction of the costs of acquiring the self-test kits through the provision of subsidies, and ensuring consistent availability of the self-test kits. CONCLUSIONS:Key stakeholders expressed confidence in HIVST's ability to improve the uptake of HIV testing services. However, they reported challenges, which need to be addressed to ensure successful implementation and scale-up of the HIVST. There is a need for further research incorporating lower level stakeholders to fully understand HIVST implementation and scale-up challenges and strategies to inform policy.

Project description:BackgroundTargeted HIV testing strategies are needed to reach remaining undiagnosed people living with HIV and achieve the UNAIDS' 95-95-95 goals for 2030. HIV self-testing (HIVST) can increase uptake of HIV testing among young people, but user perspectives on novel distribution methods are uncertain. We assess the acceptability, perceived challenges, and recommendations of young adult lay counselor-led campus-based HIVST delivery among tertiary school students aged 18-24 years in Zimbabwe.MethodsWe purposively sampled participants from an intervention involving campus-based HIVST using lay workers for distribution. We conducted in-depth interviews (IDIs) and focus group discussions (FGDs) among young adults from 10 universities and colleges in Zimbabwe who: (1) self-tested on campus; (2) self-tested off campus; and (3) opted not to self-test. We audio recorded and transcribed all interviews. Using applied thematic analysis, two investigators identified emergent themes and independently coded transcripts, achieving high inter-coder agreement.ResultsOf the 52 young adults (53.8% male, 46.1% female) interviewed through 26 IDIs and four FGDs, most IDI participants (19/26, 73%) favored campus-based HIVST, describing it as a more autonomous, convenient, and socially acceptable experience than other facility or community-based HIV testing services. Despite general acceptability, participants identified challenges with this delivery model, including: perceived social coercion, insufficient privacy and access to post-test counseling. These challenges influenced some participants to opt against self-testing (6/52, 11.5%). Recommendations for improved implementation included integrating secondary distribution of test kits and increased HIV counseling options into campus-based programs.ConclusionsBarriers to HIV testing among young people are numerous and complex. As the number of new HIV infections among youth continue to grow worldwide, targeted strategies and youth friendly approaches that increase access to testing are needed to close the diagnostic coverage gap. This is the first study to describe young adult acceptance of campus-based delivery of HIVST by lay counselors in Zimbabwe.

Project description:Since 2019, the ATLAS project, coordinated by Solthis in collaboration with national AIDS programs, has introduced, promoted and delivered HIV self-testing (HIVST) in Côte d'Ivoire, Mali and Senegal. Several delivery channels have been defined, including key populations: men who have sex with men, female sex workers and people who use injectable drugs. At project initiation, a qualitative study analyzing the perceptions and attitudes of key stakeholders regarding the introduction of HIVST in their countries and its integration with other testing strategies for key populations was conducted. The study was conducted from September to November 2019 within 3 months of the initiation of HIVST distribution. Individual interviews were conducted with 60 key informants involved in the project or in providing support and care to key populations: members of health ministries, national AIDS councils, international organizations, national and international non-governmental organizations, and peer educators. Semi structured interviews were recorded, translated when necessary, and transcribed. Data were coded using Dedoose© software for thematic analyses. We found that stakeholders' perceptions and attitudes are favorable to the introduction and integration of HIVST for several reasons. Some of these reasons are held in common, and some are specific to each key population and country. Overall, HIVST is considered able to reduce stigma; preserve anonymity and confidentiality; reach key populations that do not access testing via the usual strategies; remove spatial barriers; save time for users and providers; and empower users with autonomy and responsibility. It is non-invasive and easy to use. However, participants also fear, question and doubt users' autonomy regarding their ability to use HIVST kits correctly; to ensure quality secondary distribution; to accept a reactive test result; and to use confirmation testing and care services. For stakeholders, HIVST is considered an attractive strategy to improve access to HIV testing for key populations. Their doubts about users' capacities could be a matter for reflective communication with stakeholders and local adaptation before the implementation of HIVST in new countries. Those perceptions may reflect the West African HIV situation through the emphasis they place on the roles of HIV stigma and disclosure in HIVST efficiency.

Project description:BACKGROUND:HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. METHODS AND FINDINGS:Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05-1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 (N = 144) and 4 months (N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing. CONCLUSIONS:In this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high. TRIAL REGISTRATION:ClinicalTrials.gov NCT02827240.

Dataset Information

Regulation of HIV self-testing in Malawi, Zambia and Zimbabwe: a qualitative study with key stakeholders.

Publications

Regulation of HIV self-testing in Malawi, Zambia and Zimbabwe: a qualitative study with key stakeholders.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets