HivNCT04858243
Engaging Men Through HIV Self-Testing With Differentiated Care to Improve ART Initiation and Viral Suppression Among Men in Malawi
A study testing Home-Based ART and Facility-Based ART in people with Hiv, run by University of California, Los Angeles at 1 site in Malawi.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Home-Based ART and Facility-Based ART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 930 participants
- Where
- 1 siteMalawi
- Study dates
- 2 Aug 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hiv
- Being tested
- Home-Based ART, Facility-Based ART
- Keywords
- HIV, Men, HIV Self-Testing, ART Initiation, ART Retention, Home-Based care, Antiretroviral Therapy, Viral Suppression, Sub-Saharan Africa, Malawi
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based ARTOther
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.
Facility-Based ARTOther
Community-based male-specific counseling followed by linkage to a local health facility for ART initiation and continuation.
| Study group | Role | What they receive |
|---|---|---|
| Facility-Based ART | Active comparator | Men escorted to nearest health facility for ART initiation and continuation. Receives: Other: Facility-Based ART |
| Home-Based ART | Experimental | Home-based ART initiation and continuation provided for 3-months. Receives: Other: Home-Based ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month viral suppression among men living with HIV
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.
Measured: 12 months
Secondary outcomes (3)
ART Initiation
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.
Measured: 6 months
ART Retention
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.
Measured: 18 months
Proportion of female clients and men who self-report at least one adverse event
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start2 Aug 2021
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 930 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Partners in Hope, Inc., Medical University of South Carolina, Charles University, Czech Republic, University of Cape Town, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thomas J. Coates, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858243
- Sponsor's protocol ID
- R01MH122308
- Other IDs
- R01MH122308-01A1
- Status last verified
- May 2023
- First submitted
- 21 Apr 2021
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Holland KN, Hubbard J, Mphande M, Robson I, Phiri K, Onoya D, Chikuse E, Dovel K, Choko AT. Implementation of male-specific motivational interviewing in Malawi: an assessment of intervention fidelity and barriers to scale-up. BMJ Glob Health. 2026 Mar 31;11(3):e018269. doi: 10.1136/bmjgh-2024-018269.
PubMed 41916615Hubbard J, Mphande M, Robson I, Balakasi K, Phiri K, Chikuse E, Thorp M, Phiri S, Choko AT, Cornell M, Coates T, Dovel K. Core components of male-specific person-centred HIV care: a qualitative analysis from client and healthcare worker perspectives in Malawi. BMJ Public Health. 2024 Dec 22;2(2):e001100. doi: 10.1136/bmjph-2024-001100. eCollection 2024 Dec.
PubMed 40018627Holland KN, Hubbard J, Mphande M, Robson I, Phiri K, Onoya D, Chikuse E, Dovel K, Choko A. Implementation of Male-Specific Motivational Interviewing in Malawi: An Assessment of Intervention Fidelity and Barriers to Scale-Up. medRxiv [Preprint]. 2024 Sep 26:2024.09.24.24314326. doi: 10.1101/2024.09.24.24314326.
PubMed 39399024Choko AT, Coates TJ, Mphande M, Balakasi K, Robson I, Phiri K, Phiri S, Kulich M, Sweat M, Cornell M, Hoffman RM, Dovel K. Engaging men through HIV self-testing with differentiated care to improve ART initiation and viral suppression among men in Malawi (ENGAGE): A study protocol for a randomized control trial. PLoS One. 2023 Feb 24;18(2):e0281472. doi: 10.1371/journal.pone.0281472. eCollection 2023.
PubMed 36827327
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Men Through HIV Self-Testing With Differentiated Care to Improve ART Initiation and Viral Suppression Among Men in Malawi
- ClinicalTrials.gov ID
- NCT04858243
- Acronym / sponsor ID
- R01MH122308
- Conditions
- Hiv
- Keywords
- HIV, Men, HIV Self-Testing, ART Initiation, ART Retention, Home-Based care, Antiretroviral Therapy, Viral Suppression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 930 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Partners in Hope, Inc., Medical University of South Carolina, Charles University, Czech Republic, University of Cape Town, National Institute of Mental Health (NIMH)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facility-Based ART | Active comparator | Other: Facility-Based ARTMen escorted to nearest health facility for ART initiation and continuation. |
| Home-Based ART | Experimental | Other: Home-Based ARTHome-based ART initiation and continuation provided for 3-months. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based ARTCommunity-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. | Other | Home-Based ART |
| Facility-Based ARTCommunity-based male-specific counseling followed by linkage to a local health facility for ART initiation and continuation. | Other | Facility-Based ART |
Primary outcome
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.
3 secondary outcomes
ART Initiation
Time frame: 6 months
ART Retention
Time frame: 18 months
Proportion of female clients and men who self-report at least one adverse event
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Derived from this study: PubMed 41916615Holland KN, Hubbard J, Mphande M, Robson I, Phiri K, Onoya D, Chikuse E, Dovel K, Choko AT. Implementation of male-specific motivational interviewing in Malawi: an assessment of intervention fidelity and barriers to scale-up. BMJ Glob Health. 2026 Mar 31;11(3):e018269. doi: 10.1136/bmjgh-2024-018269.
- Derived from this study: PubMed 40018627Hubbard J, Mphande M, Robson I, Balakasi K, Phiri K, Chikuse E, Thorp M, Phiri S, Choko AT, Cornell M, Coates T, Dovel K. Core components of male-specific person-centred HIV care: a qualitative analysis from client and healthcare worker perspectives in Malawi. BMJ Public Health. 2024 Dec 22;2(2):e001100. doi: 10.1136/bmjph-2024-001100. eCollection 2024 Dec.
- Derived from this study: PubMed 39399024Holland KN, Hubbard J, Mphande M, Robson I, Phiri K, Onoya D, Chikuse E, Dovel K, Choko A. Implementation of Male-Specific Motivational Interviewing in Malawi: An Assessment of Intervention Fidelity and Barriers to Scale-Up. medRxiv [Preprint]. 2024 Sep 26:2024.09.24.24314326. doi: 10.1101/2024.09.24.24314326.
- Derived from this study: PubMed 36827327Choko AT, Coates TJ, Mphande M, Balakasi K, Robson I, Phiri K, Phiri S, Kulich M, Sweat M, Cornell M, Hoffman RM, Dovel K. Engaging men through HIV self-testing with differentiated care to improve ART initiation and viral suppression among men in Malawi (ENGAGE): A study protocol for a randomized control trial. PLoS One. 2023 Feb 24;18(2):e0281472. doi: 10.1371/journal.pone.0281472. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based ART and Facility-Based ART in people with Hiv, run by University of California, Los Angeles at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month viral suppression among men living with HIV (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04858243, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.