Identifying Efficient Linkage Strategies for Men

HIV self-testing (HIVST) has been found to be a highly acceptable approach for men to learn of their HIV status and has resulted in increased testing uptake. However, rates of antiretroviral therapy (ART) initiation among those tested with HIVST are difficult to capture. This clinical trial will test varying approaches to ART initiation and retention among men who test positive using HIVST to learn about the most effective strategy to engage men in ART services.

Sex

All

Minimum age

15 Years

Men:

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)

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)

Female partner

Inclusion Criteria:

* ≥15 years of age
* Male partner enrolled in the study
* Male partner agrees that the female can be recruited for an in-depth interview

Exclusion Criteria:

* \<15 years of age
* Male partner is not enrolled in the study
* Male partner does not agree that the female can be recruited for an in-depth interview

• 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
• DERIVEDDovel K, Balakasi K, Hubbard J, Phiri K, Nichols BE, Coates TJ, Kulich M, Chikuse E, Phiri S, Long LC, Hoffman RM, Choko AT. Identifying efficient linkage strategies for men (IDEaL): a study protocol for an individually randomised control trial. BMJ Open. 2023 Jul 12;13(7):e070896. doi: 10.1136/bmjopen-2022-070896. PMID 37438067