Clinical trial NCT03541382: A Cluster Randomised Trial of Community-led Distribution of HIV Self-tests in Rural Malawi (HIV Self-Testing Africa [STAR])
Official title: Community-led Distribution of HIV Self-tests: a Cluster Randomised Trial Investigating Uptake of HIV Testing and Linkage to Treatment and Prevention, Costs and Safety in Rural Malawi (HIV Self-Testing Africa [STAR])
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV
HIV Self-Testing
Malawi
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
name: Liverpool School of Tropical Medicine
name: University College, London
name: Population Services International
name: UNITAID
First posted: 2018-05-30
Enrollment: 7880
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to determine the benefits, costs and safety of community-led delivery of HIV self-testing (HIVST) kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.

Detailed description: RESEARCH QUESTION

Can community-led delivery of HIV self-tests be used to maximise public health and social benefits and reduce costs without introducing social harms?

RESEARCH AIMS AND OBJECTIVES

The broad aim is to determine the benefits, costs and safety of community-led delivery of HIVST kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.

The specific objectives are to conduct a cluster randomised controlled trial to:

1. Establish the effectiveness of community-led HIVST campaigns on lifetime and recent HIV testing in predefined sub-groups.
2. Investigate the impact of community-led HIVST campaigns on: (a) population-level initiation of antiretroviral therapy (ART) and uptake of voluntary medical male circumcision (VMMC), (b) knowledge of HIV prevention, (c) stigma reduction
3. Explore how differences in community-led HIVST campaigns affect uptake of HIVST and linkage to care and prevention and values, attitudes and behaviours around HIVST.
4. Estimate the costs and cost-effectiveness of community-led HIVST campaigns compared to the standard of care (SOC).

RESEARCH DESIGN

The main study consists of a cluster-randomised trial evaluating the effectiveness of community-led HIVST campaigns on coverage of HIV testing and linkage to follow-on services compared to the Ministry of Health (MoH) SOC, facility-based HIV testing services (HTS). We are also interested in understanding the cost-effectiveness of community-led HIVST campaigns, and broader social benefits on stigma reduction.

The unit of randomisation is the Group Village Head (GVH), who are traditionally-appointed leaders that oversee a group of villages, and their catchments areas. Outcomes are measured through (i) household surveys in evaluation villages selected for each study cluster, and (ii) clinic records of patients coming from the study clusters.

For the primary outcome, measured using the households surveys, we assume that lifetime testing rates for adolescents aged 15-19 years old in the SOC arm are 35-50%, based on the recent Demographic and Health Survey. With 16 clusters per arm and 50 adolescents per cluster, we will have at least 90% power to detect a 20% absolute increase in lifetime testing using a coefficient of variation of outcomes (k) of 0.25. If k=0.3, for a 20% increase in lifetime testing, we would have 90% and 80% power with SOC testing rates of 35-40% and 45-55%, respectively. If the absolute increase in lifetime testing is lower at 15%, then for k=0.25 we would have 80% power for SOC testing rates of 35-40%. With adolescents making up 20-25% of the adult population, this will require 250 adults per cluster.

SUB-STUDIES

We will also be conducting a series of sub-studies related to the trial, including:

1. Process evaluation to monitor progress of the intervention and adherence to guidelines, and understand how differences in the context-driven intervention affect HIVST uptake and linkage to care and prevention.
2. Qualitative evaluation to explore which aspects of the community-led intervention were pivotal in affecting HIV testing and linkage outcomes and values, attitudes and behaviours around HIVST.
3. Economic evaluation to estimate costs, cost-effectiveness and cost-benefit per individual tested, newly diagnosed as HIV positive, started on ART and circumcised.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 15 years
* Residence in GVH catchment areas included in the intervention arm

Exclusion Criteria:

* Aged \< 15 years old
* Not resident in GVH catchment areas included in the intervention arm

Primary outcomes:
measure: Percentage of self-reported lifetime testing in adolescents aged 15-19 years old
timeFrame: Measured 8-12 weeks post-intervention
Secondary outcomes:
measure: Percentage of self-reported testing in last 3 months in men aged ≥ 15 years
timeFrame: Measured 8-12 weeks post-intervention
measure: Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years
timeFrame: Measured 8-12 weeks post-intervention
measure: Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months
timeFrame: Measured 6-months post-intervention
measure: Measure of knowledge of HIV prevention methods
timeFrame: Measured 8-12 weeks post-intervention
measure: Measure of HIV testing stigma.
timeFrame: Measured 8-12 weeks post-intervention
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Study officials:
References:
citation: Indravudh PP, Fielding K, Sande LA, Maheswaran H, Mphande S, Kumwenda MK, Chilongosi R, Nyirenda R, Johnson CC, Hatzold K, Corbett EL, Terris-Prestholt F. Pragmatic economic evaluation of community-led delivery of HIV self-testing in Malawi. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004593. doi: 10.1136/bmjgh-2020-004593.
citation: Indravudh PP, Fielding K, Kumwenda MK, Nzawa R, Chilongosi R, Desmond N, Nyirenda R, Neuman M, Johnson CC, Baggaley R, Hatzold K, Terris-Prestholt F, Corbett EL. Effect of community-led delivery of HIV self-testing on HIV testing and antiretroviral therapy initiation in Malawi: A cluster-randomised trial. PLoS Med. 2021 May 11;18(5):e1003608. doi: 10.1371/journal.pmed.1003608. eCollection 2021 May.
citation: Indravudh PP, Fielding K, Kumwenda MK, Nzawa R, Chilongosi R, Desmond N, Nyirenda R, Johnson CC, Baggaley RC, Hatzold K, Terris-Prestholt F, Corbett EL. Community-led delivery of HIV self-testing to improve HIV testing, ART initiation and broader social outcomes in rural Malawi: study protocol for a cluster-randomised trial. BMC Infect Dis. 2019 Sep 18;19(1):814. doi: 10.1186/s12879-019-4430-4.