Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi

Study Overview
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Brief Summary
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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
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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.

Official Title
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Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi

Conditions
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Hiv

Intervention / Treatment
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* Other: Home-Based ART
* Other: Facility-Based ART


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hbART<br>Home-Based ART initiation and continuation for 3-months with male-specific counseling and assisted facility navigation at 4-months. | Other: Home-Based ART<br>* 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.<br>|
| Active Comparator: fbART<br>Facility-Based ART initiation and continuation with male-specific counseling. | Other: Facility-Based ART<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Men's ART Initiation | ART initiation within 6-months of enrollment. Sourced from medical chart reviews. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Men's 6-month Retention | 6-month retention (<60 days ever late for ART). Sourced from medical chart reviews. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HIV Self-Testing, HIVST, Index HIVST, Index Testing, Men, Male Partners, Antiretroviral therapy, ART initiation, Home-based ART, ART retention