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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541382
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : November 15, 2019
Sponsor:
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  ICMJE May 17, 2018
First Posted Date  ICMJE May 30, 2018
Last Update Posted Date November 15, 2019
Actual Study Start Date  ICMJE October 8, 2018
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
Percentage of self-reported lifetime testing in adolescents aged 15-19 years old [ Time Frame: Measured 3-months post-intervention ]
Original Primary Outcome Measures  ICMJE
 (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 ]
Change History Complete list of historical versions of study NCT03541382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • Percentage of self-reported testing in last 3 months in men aged ≥ 15 years [ Time Frame: Measured 3-months post-intervention ]
  • Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years [ Time Frame: Measured 3-months post-intervention ]
  • Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months [ Time Frame: Measured 6-months post-intervention ]
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE A Cluster Randomised Trial of Community-led Distribution of HIV Self-tests in Rural Malawi (HIV Self-Testing Africa [STAR])
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE HIV/AIDS
Intervention  ICMJE 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  ICMJE
  • 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, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2019)
7880
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
8000
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03541382
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Yes
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme
  • Liverpool School of Tropical Medicine
  • University College, London
  • Population Services International
  • UNITAID
Investigators  ICMJE Not Provided
PRS Account London School of Hygiene and Tropical Medicine
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP