A Cluster Randomised Trial of Community-led Distribution of HIV Self-tests in Rural Malawi (HIV Self-Testing Africa [STAR])

• ClinicalTrials.gov Identifier: NCT03541382
• Recruitment Status: Completed
• First Posted: May 30, 2018
• Last Update Posted: August 11, 2020
• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Malawi-Liverpool-Wellcome Trust Clinical Research Programme; Liverpool School of Tropical Medicine; University College, London; Population Services International; UNITAID
• Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine

Tracking Information

• First Submitted Date: May 17, 2018
• First Posted Date: May 30, 2018
• Last Update Posted Date: August 11, 2020
• Actual Study Start Date: October 8, 2018
• Actual Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 7, 2020): Percentage of self-reported lifetime testing in adolescents aged 15-19 years old [ Time Frame: Measured 8-12 weeks post-intervention ]

Original Primary Outcome Measures (submitted: May 17, 2018)

• Percentage of self-reported lifetime testing in adolescents aged 15-19 years old [ Time Frame: Month 1 ]
• Percentage of self-reported recent testing in adults aged ≥ 15 years [ Time Frame: Month 13 ]

Current Secondary Outcome Measures (submitted: August 7, 2020)

• Percentage of self-reported testing in last 3 months in men aged ≥ 15 years [ Time Frame: Measured 8-12 weeks post-intervention ]
• Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years [ Time Frame: Measured 8-12 weeks post-intervention ]
• Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months [ Time Frame: Measured 6-months post-intervention ]
• Measure of knowledge of HIV prevention methods [ Time Frame: Measured 8-12 weeks post-intervention ]
• Measure of HIV testing stigma. [ Time Frame: Measured 8-12 weeks post-intervention ]

Original Secondary Outcome Measures (submitted: May 17, 2018)

• Percentage of self-reported recent testing in men aged ≥ 15 years [ Time Frame: Month 1 ]
• Percentage of self-reported recent testing in adults aged ≥ 40 years [ Time Frame: Month 1 ]
• Cumulative incidence of population-level ART and VMMC uptake in adults aged ≥ 15 years over six months (composite measure) [ Time Frame: Month 6 ]
• Knowledge of HIV prevention score [ Time Frame: Months 1 and 13 ]
• HIV stigma score [ Time Frame: Months 1 and 13 ]
• Costs per individual tested, newly diagnosed as HIV positive, started on ART and circumcised [ Time Frame: Months 1 and 13 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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])
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Diagnostic
• Condition: HIV/AIDS

Intervention

Device: OraQuick® HIV Self-Test

Community leaders, including GVHs, Village Health Committee members, Village Development Committee members, and members of key community groups will participate in a workshop to facilitate planning of a HIVST campaign. Identified community distributors, who are unpaid volunteers from the community, will also receive a training package in HIVST promotion.

Campaigns will be conducted over a short period (approximately seven days) and under a fixed budget. Community distributors will deliver HIVST kits free of charge to community members, and provide information on how to self-test and access the nearest clinic for linkage to confirmatory HTS, treatment and prevention. Distributors will also provide HIV prevention messages around serodiscordancy, treatment as prevention and VMMC.

Study Arms

• Active Comparator: HIVST campaign arm
  Community representatives will be supported to plan and administer an HIVST campaign linked to HIV care and prevention services in their communities.
  Intervention: Device: OraQuick® HIV Self-Test
• No Intervention: SOC arm
  Standard HTS will be provided by MoH at health facilities.

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 13, 2019): 7880
• Original Estimated Enrollment (submitted: May 17, 2018): 8000
• Actual Study Completion Date: July 31, 2019
• Actual Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Malawi

Administrative Information

• NCT Number: NCT03541382
• Other Study ID Numbers: 14761
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: London School of Hygiene and Tropical Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: London School of Hygiene and Tropical Medicine
• Original Study Sponsor: Same as current

Collaborators

• Malawi-Liverpool-Wellcome Trust Clinical Research Programme
• Liverpool School of Tropical Medicine
• University College, London
• Population Services International
• UNITAID

• Investigators: Not Provided
• PRS Account: London School of Hygiene and Tropical Medicine
• Verification Date: November 2019