Clinical trial · Interventional
Engaging Men Through HIV Self-Testing With Differentiated Care to Improve ART Initiation and Viral Suppression Among Men in Malawi
NCT04858243CI-TRIAL-00066436unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 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.
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
- ACTIVE_COMPARATOR
- label
- Facility-Based ART
- description
- Men escorted to nearest health facility for ART initiation and continuation.
- interventionNames
- Other: Facility-Based ART
- type
- EXPERIMENTAL
- label
- Home-Based ART
- description
- Home-based ART initiation and continuation provided for 3-months.
- interventionNames
- Other: Home-Based ART
Primary outcomes (1)
- measure
- 6-month viral suppression among men living with HIV
- timeFrame
- 12 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 (4)
- DERIVEDHolland 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. PMID 41916615
- DERIVEDHubbard 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. PMID 40018627
- DERIVEDHolland 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. PMID 39399024
- DERIVEDChoko 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. PMID 36827327