Clinical trial · Interventional
Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 \[209 females, 261 males\]
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hiv | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Facility-Based ART | Other | — | UNRESOLVED |
| Home-Based ART | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hbART
- description
- Home-Based ART initiation and continuation for 3-months with male-specific counseling and assisted facility navigation at 4-months.
- interventionNames
- Other: Home-Based ART
- type
- ACTIVE_COMPARATOR
- label
- fbART
- description
- Facility-Based ART initiation and continuation with male-specific counseling.
- interventionNames
- Other: Facility-Based ART
Primary outcomes (1)
- measure
- Men's ART Initiation
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available