Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K01TW011484 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Partners in Hope, Inc. | INDUSTRY |
| Fogarty International Center of the National Institute of Health | NIH |
Not provided
Not provided
Not provided
Not provided
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]
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hbART | Experimental | Home-Based ART initiation and continuation for 3-months with male-specific counseling and assisted facility navigation at 4-months. |
|
| fbART | Active Comparator | Facility-Based ART initiation and continuation with male-specific counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-Based ART | Other | Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and ART initiation with a 30-day supply. Monthly home-based ART follow-up visits with male-specific messaging and 30-day supply distribution will take place for 3-months. At 4-months providers will provide assisted linkage to a nearby facility to join the facility-based ART program. Additional counseling will be provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Men's ART Initiation | ART initiation within 6-months of enrollment. Sourced from medical chart reviews. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Men's 6-month Retention | 6-month retention (<60 days ever late for ART). Sourced from medical chart reviews. | 6 months |
Not provided
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:
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:
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partners in Hope | Lilongwe | Malawi |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Facility-Based ART | Other | Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and assisted linkage to a nearby facility for facility-based ART initiation and continuation. Male clients will receive a 30-day supply each visit and return monthly. |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |