Clinical trial NCT04878601: Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi
Official title: Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hiv
Keywords: HIV
HIV Self-Testing
HIVST
Index HIVST
Index Testing
Men
Male Partners
Antiretroviral therapy
ART initiation
Home-based ART
ART retention
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Partners in Hope, Inc.
name: Fogarty International Center of the National Institute of Health
First posted: 2021-05-07
Enrollment: 470
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: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Men's ART Initiation
timeFrame: 6 months
Secondary outcomes:
measure: Men's 6-month Retention
timeFrame: 6 months
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Partners in Hope
Study officials:
References: