Clinical trial NCT05137210: Identifying Efficient Linkage Strategies for Men
Official title: Identifying Efficient Linkage Strategies for Men
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hiv
Keywords: HIV self-testing (HIVST)
HIV
Antiretroviral therapy (ART)
ART Initiation
ART Retention
Men
HIVST
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Partners in Hope, Inc.
name: Boston University
name: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
name: Charles University, Czech Republic
name: Bill and Melinda Gates Foundation
First posted: 2021-11-30
Enrollment: 569
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 and some studies have suggested that linkage rates are low , particularly amongst men. The investigators propose a clinical trial to test varying approaches to ART initiation and retention among men who test HIV-positive through HIVST. Three interventions will be tested:

Standard of Care (Arm 1): phone and in-person follow-up, accompanied with male-specific counseling (given every two weeks for up to 90-days or until ART initiation is achieved, whichever comes first); Home-Based ART initiation (Arm 2): nurse-led ART initiation at home or in the community Staged Intervention (Arm 3): a staged intervention that consecutively increases in intensity every month that a participant does not initiate ART (intervals include: Days 1-14: Standard of Care; Days 14-30: Peer support with a psychosocial consellor; Days 30-90: Nurse-led Home-Based ART initiation);

The primary objective is to identify a cost-effective package comprised of male-specific counseling, peer support, community ART distribution and/or home-based ART services for ART initiation and retention among men identified as HIV-positive through HIVST in Malawi. The specific objectives are:

Aim 1. Evaluate the effectiveness of the Stepped ART Intervention (Arm 3) vs male counseling and facility navigation (Arm 1) (primary analysis) and the effectiveness of the Stepped ART Intervention (Arm 3) vs home-based ART initiation with a nurse (Arm 2) (secondary analysis) on ART initiation within 4-months after enrollment in the trial.

Aim 2. Identify individual-, community-, and facility-level factors associated with ART initiation within each intervention arm (male counseling, home-based ART and Stepped intervention) using baseline and semi-structured in-depth interviews.

Aim 3. Determine the cost-effectiveness and scalability of the intervention arms through costing and mathematical modeling.

An individually randomized control trial will be performed with 545 HIV-positive men. Men will be individually randomized 1:1:1 to one of the three intervention arms described above. They will receive their assigned intervention over the course of three months or until the participant initiates ART. The study will be preformed at 10 health facilities supported by Partners in Hope (PIH). Data collection will include baseline and follow-up surveys at 2- and 4-months; medical charter reviews at 2- and 4-months after study enrollment; qualitative interviews with a subset of men and their female partners; and a cost analysis of costs associated with each arm. Male participants will be enrolled in the study for a total of 4 months.

The investigators anticipate learning about the most effective stragty to engage men in ART. The investigators also anticipate learning about the type and degree of followup necessary to support men's engagement in ART services. Finally, the investigators anticipate learning about the cost-effectiveness of intervention, with the goal of improving cost-effectiveness for the Ministry of Health. Results from this study could be used to define best practices and to further scale ART-focused programs for men in Malawi.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of men who are retained on ART early
timeFrame: 4-months.
Secondary outcomes:
measure: Proportion of men who initiate ART
timeFrame: 3-months
measure: Any adverse events self-reported by female ART client or male partner
timeFrame: 4-months
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Partners in Hope
Study officials:
References: