HivNCT04878601
Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive 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 are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. 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
- 470 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Jul 2021to 31 Mar 2024
- 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 are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. Home-based ART may improve ART initiation and retention among male partners who test HIV-positive through Index HIV self-testing (HIVST). We will pilot an intervention that provides home-based ART initiation and home-based continuation for 3-months, followed by assisted linkage to facility-based care at 4-months. 470 participants will be enrolled [209 females, 261 males]
Read the detailed description
Men in Sub-Saharan Africa are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Achieving epidemic control requires immediate, concentrated effort to engage this largely unreached population. Index partner testing, whereby partners of HIV-positive clients are refereed for HIV testing, is critical to identifying undiagnosed men and has been adopted as a national policy by the Malawi Ministry of Health because of its high acceptability and its dramatic increase on HIV testing uptake. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. Home-based ART may improve ART initiation and retention among male partners who test HIV-positive through Index HIVST. We will pilot an intervention that provides home-based ART initiation and home-based continuation for male partners identified as HIV-positive through Index HIVST for 3-months, followed by assisted linkage to facility-based care at 4-months. This intervention offers opt-out ART and in-depth, male-specific counseling for 3-months before linking men to facility based care. We will directly compare home-based ART to facility-based ART, whereby a health care worker will conduct a home-visit with HIV+ male partners to provide confirmatory HIV testing and immediate assisted linkage to a nearby facility for facility-based ART initiation and continuation.
- Conditions
- Hiv
- Being tested
- Home-Based ART, Facility-Based ART
- Keywords
- HIV, HIV Self-Testing, HIVST, Index HIVST, Index Testing, Men, Male Partners, Antiretroviral therapy, ART initiation, Home-based ART, ART retention
- 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
Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and ART initiation with a 30-day supply. Monthly home-based ART follow-up visits with male-specific messaging and 30-day supply distribution will take place for 3-months. At 4-months providers will provide assisted linkage to a nearby facility to join the facility-based ART program. Additional counseling will be provided.
Facility-Based ARTOther
Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and assisted linkage to a nearby facility for facility-based ART initiation and continuation. Male clients will receive a 30-day supply each visit and return monthly.
| Study group | Role | What they receive |
|---|---|---|
| hbART | Experimental | Home-Based ART initiation and continuation for 3-months with male-specific counseling and assisted facility navigation at 4-months. Receives: Other: Home-Based ART |
| fbART | Active comparator | Facility-Based ART initiation and continuation with male-specific counseling. Receives: Other: Facility-Based ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Men's ART Initiation
ART initiation within 6-months of enrollment. Sourced from medical chart reviews.
Measured: 6 months
Secondary outcomes (1)
Men's 6-month Retention
6-month retention (<60 days ever late for ART). Sourced from medical chart reviews.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Partners in Hope, Inc., Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Kathryn L. Dovel, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878601
- Sponsor's protocol ID
- K01TW011484
- Other IDs
- K01TW011484
- Status last verified
- Jun 2023
- First submitted
- 4 May 2021
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi
- ClinicalTrials.gov ID
- NCT04878601
- Acronym / sponsor ID
- K01TW011484
- Conditions
- Hiv
- Keywords
- HIV, HIV Self-Testing, HIVST, Index HIVST, Index Testing, Men, Male Partners, Antiretroviral therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Partners in Hope, Inc., Fogarty International Center of the National Institute of Health
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 7 May 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 are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. Home-based ART may improve ART initiation and retention among male partners who test HIV-positive through Index HIV self-testing (HIVST). We will pilot an intervention that provides home-based ART initiation and home-based continuation for 3-months, followed by assisted linkage to facility-based care at 4-months. 470 participants will be enrolled [209 females, 261 males]
Detailed description
Men in Sub-Saharan Africa are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease. Achieving epidemic control requires immediate, concentrated effort to engage this largely unreached population. Index partner testing, whereby partners of HIV-positive clients are refereed for HIV testing, is critical to identifying undiagnosed men and has been adopted as a national policy by the Malawi Ministry of Health because of its high acceptability and its dramatic increase on HIV testing uptake. Two overarching barriers keep HIV-positive men from accessing ART services: 1) Lack of male-friendly services, and 2) harmful gender norms. Home-based ART may improve ART initiation and retention among male partners who test HIV-positive through Index HIVST. We will pilot an intervention that provides home-based ART initiation and home-based continuation for male partners identified as HIV-positive through Index HIVST for 3-months, followed by assisted linkage to facility-based care at 4-months. This intervention offers opt-out ART and in-depth, male-specific counseling for 3-months before linking men to facility based care. We will directly compare home-based ART to facility-based ART, whereby a health care worker will conduct a home-visit with HIV+ male partners to provide confirmatory HIV testing and immediate assisted linkage to a nearby facility for facility-based ART initiation and continuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hbART | Experimental | Other: Home-Based ARTHome-Based ART initiation and continuation for 3-months with male-specific counseling and assisted facility navigation at 4-months. |
| fbART | Active comparator | Other: Facility-Based ARTFacility-Based ART initiation and continuation with male-specific counseling. |
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 ARTHealthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and ART initiation with a 30-day supply. Monthly home-based ART follow-up visits with male-specific messaging and 30-day supply distribution will take place for 3-months. At 4-months providers will provide assisted linkage to a nearby facility to join the facility-based ART program. Additional counseling will be provided. | Other | hbART |
| Facility-Based ARTHealthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and assisted linkage to a nearby facility for facility-based ART initiation and continuation. Male clients will receive a 30-day supply each visit and return monthly. | Other | fbART |
Primary outcome
Men's ART Initiation
Time frame: 6 months
ART initiation within 6-months of enrollment. Sourced from medical chart reviews.
1 secondary outcome
Men's 6-month Retention
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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 26 Jun 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?
Men's ART Initiation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2023.