Engaging Men Through HIV Self-Testing With Differentiated Care to Improve ART Initiation and Viral Suppression Among Men in Malawi

May 12, 2023 updated by: Thomas J. Coates, University of California, Los Angeles
Men in sub-Saharan Africa who test HIV-positive continue to have poor ART initiation and retention outcomes. The proposed project will test a home-based ART intervention for men who are living with HIV compared to facility-based ART. Findings will provide essential information on how to best reach men across the testing and treatment continuum, a critical step to curbing the HIV epidemic.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Men in sub-Saharan Africa are less likely than women to use HIV services. HIV testing strategies have dramatically improved for men through HIV self-testing (HIVST) and other male-focused strategies, but men who are identified as living with HIV are still less likely than women to initiate ART or remain in care, particularly within the first several months after initiation. In Malawi, men represent only 31% of new ART initiates2 - and men on ART are more likely than women to be lost to follow up (LTFU) at all time intervals of care than women. Men's absence from care is concerning not only for their own health, but also for the health of girls and young women who continue to be infected at unacceptably high rates. Offering ART at home or other locations convenient for men (i.e., home-based ART) for a brief period of time may help men overcome barriers related to facility-based treatment, develop coping strategies for ART engagement, and better engage in facility-based services over the long-term. In this study we will assess the impact of hbART by comparing two arms:

Facility-Based ART (fbART arm): community-based male-specific counseling followed by linkage to a local health facility for ART initiation and continuation.

Home-Based ART (hbART arm): community-based male-specific counseling followed by home-based ART initiation (or at any location that is convenient for participants) and home-based ART continuation for a 3-month period, followed by linkage to a local health facility for further ART continuation.

Objective: Our primary objective is to compare the impact of home-based ART against standard of care for ART initiation and retention among men identified as HIV-positive through HIVST in Malawi. Our specific Aims are:

Aim 1. Test the effectiveness of hbART versus fbART on ART initiation and 6-month viral suppression among men living with HIV.

Aim 2. Identify predictors of ART initiation and 6-month viral suppression in the hbART arm

Aim 3. Determine the cost-effectiveness and scalability of hbART at a national level.

Methods: We will perform an individually randomized control trial with 820 HIV-positive men who have not yet initiated ART and a subset of 110 of their female partners. Men will be individually randomized 1:1 to one of the two intervention arms described above and will be enrolled in the study for 18-months or until 12-month retention (secondary outcome) can be measured, whichever comes first. The study will be performed at 10 health facilities supported by Partners in Hope (PIH). Data collection will include baseline and follow-up surveys at 2-, 4-, and 7-months, as well as medical charter reviews for men at 2-, 4-, 7-, and 13-months after study enrollment. Qualitative interviews will be conducted with a subset of men and women to understand perceptions of the intervention and experiences with ART engagement, and cost data from a provider perspective will be collected for a cost analysis of each arm.

Anticipated results: Findings will establish the effectiveness of home-based ART among men living with HIV who have not yet engaged in treatment, and can directly inform HIV programs throughout the region. Findings will also help us assess if short-term home-based ART is sufficient to engage men in long-term facility-based care, or if additional, more resource-intensive services are needed, such as major changes to the structure of facility-based ART.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
930

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Malawi
      • Lilongwe, Malawi
        • Partners in Hope

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Female Partner Inclusion Criteria:

  • Male partner ≥15 years of age
  • No reported interpersonal violence (IPV) as defined by World Health Organization (WHO) with the above male partner in the past 12-months
  • Male partner ever tested HIV-positive

  • Male partner not currently engaged in ART services, defined as:

    • Tested HIV-positive ≥14 days and not on ART ≥14 days after testing HIV- positive;
    • ≥14 days late for the first four-week follow up appointment; or
    • Initiated ART but ≥60 days late for last ART appointment;
    • Male partner living inside the facility catchment area (defined as any area that Healthcare Workers (HCWs) from the study facility routinely visit for tracing purposes)

Female Partner Exclusion Criteria:

  • Male partner <15 years of age
  • Reported interpersonal violence (IPV) as defined by WHO with the above male partner in the past 12-months
  • Male partner never tested HIV positive
  • Male partner tested HIV-positive <14 days ago

  • Male partner currently engaged in ART services, defined as:

    • Initiated ART <14 days late for the first four-week follow up appointment
    • Initiated ART and <60 days late for last ART appointment
    • Male partner living outside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)

Men Living with HIV Inclusion Criteria:

  • ≥15 years of age
  • Tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)

  • Not currently engaged in ART services, defined as:

    • Tested HIV-positive ≥14 days and not on ART ≥14 days after testing HIV-positive;
    • ≥14 days late for the first four-week follow up appointment; or
    • Initiated ART but ≥60 days late for last ART appointment;
    • Has not taken ART in the past 7-days, as indicated by a point of care (POC) urine assay
    • Living inside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)

Men Living with HIV Exclusion Criteria:

  • <15 years of age
  • Never tested HIV positive using Ministry of Health standard algorithm (Determine + Unigold)
  • Tested HIV-positive <14 days ago

  • Currently engaged in ART services, defined as:

    • Initiated ART
    • <14 days late for the first four-week follow up appointment
    • Initiated ART and <60 days late for last ART appointment
    • Has taken ART in the past 7-days, as indicated by a point of care (POC) urine assay
    • Living outside the facility catchment area (defined as any area that HCWs from the study facility routinely visit for tracing purposes)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Facility-Based ART
Men escorted to nearest health facility for ART initiation and continuation.
Other: Facility-Based ART
Community-based male-specific counseling followed by linkage to a local health facility for ART initiation and continuation.
Experimental: Home-Based ART
Home-based ART initiation and continuation provided for 3-months.
Other: Home-Based ART
Community-based male-specific counseling followed by home-based ART initiation (or at any location that is convenient for participants) and home-based ART continuation for a 3-month period, followed by linkage to a local health facility for further ART continuation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-month viral suppression among men living with HIV
Time Frame: 12 months
Proportion of HIV-positive men tested HIV-positive who have an undetectable viral load 6-months after initiating ART (a maximum of 12-months after enrolling in the study). Sourced by medical chart reviews.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ART Initiation
Time Frame: 6 months
Proportion of HIV-positive male partners tested HIV-positive who initiate ART within 6-months of enrolling in the study. Sourced by medical chart reviews.
6 months
ART Retention
Time Frame: 18 months
Proportion of male partners who initiate and have never been >60 days late for ART within the first 12-months after treatment initiation (max 18 months after enrolment). Sourced by medical chart reviews.
18 months
Proportion of female clients and men who self-report at least one adverse event
Time Frame: 18 months
Self-report of adverse events (IPV, unwanted disclosure, end of relationship) from female ART client and men (unwanted disclosure) enrolled in the study. Source is follow-up surveys.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of South Carolina
Charles University, Czech Republic
National Institute of Mental Health (NIMH)
University of Cape Town
Partners in Hope, Malawi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH122308 (U.S. NIH Grant/Contract)
  • R01MH122308-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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