Protocols and tools
Approved protocols and key tools for STAR research are as follows:
Through a combination of qualitative and quantitative research, the Zambia studies aim to add to the evidence base on the acceptability, feasibility, accuracy and effective delivery strategies for HIV self-testing (HIVST) in Zambia. This is being done through a Clinical Performance Study, and an Impact Evaluation involving conducting a cluster randomised trial of community-based HIVST distribution.
Protocol for a cluster randomised trial of interventions to improve linkage to care following community-based distribution of HIV self-test kits in rural Zimbabwean communities, with supporting forms:
- Information sheet
- Informed consent forms for interviews with community-based distribution agents, clients and healthcare workers
Protocol for a study exploring the feasibility and acceptability of HIV self-testing in Zimbabwe, including piloting various models of distributing HIV self-testing kits in the general population and among female sex workers.
(a) General Population
The HIV STAR-Malawi general population protocol describes research investigating the costs and benefits of introducing HIVST to the general population in Malawi. This research includes pilot work estimating the acceptability and accuracy of self-tests among intended users; as well as a cluster-randomised impact evaluation studying the effectiveness of community self-test distribution in increasing testing uptake.
- Protocol describing all work investigating the feasibility and acceptability of HIV self-testing among the general population in rural Malawi.
- Pilot formative research on acceptability and feasibility of testing, including focus group discussions, in-depth interviews, and a study of the accuracy of the test compared with a researcher-provided rapid diagnostic test:
- Cognitive interviews assessing the usability of instructions for use and self-test packaging:
- Impact evaluation: household survey and programme data collection
Note that adolescent assent forms were also made available for studies including respondents under 18 years of age.
(b) Key Populations
The HIV-STAR Malawi key populations protocol describes research to understand the feasibility, benefits, and potential harms of introducing HIVST among female sex workers (FSW) in Malawi. This includes formative research to understand the testing needs of FSW, and piloting peer-led distribution of HIVST, and monitoring of social harms resulting from the introduction of HIVST.
- Protocol describing all research on the acceptability of introducing HIVST to FSW in Malawi.
- Formative research on testing needs:
- Piloting HIVST distribution and monitoring harms:
- Serial Biographical Interview guide (PS903)
- Critical Incident Interview guide (PS904)
- Focus Group Discussion (FGD) guide, peer distributor (PS905A)
- Audio Computer-Assisted Self-Interview (ACASI) questionnaire, FSW (PS901A)
- ACASI and Longitudinal Diary Study participant information sheet (PS09A) and consent form (PS09B). Note: Participant information sheets and consent forms for Serial Biographical Interview (PS09D), Critical Incident Interview (PS09F), FGD distributors (PS09H), and FGD for female sex workers and men who have sex with men (PS09H) are similar.