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Published on: October 31, 2010
Engaging men through HIV self-testing with differentiated care to improve ART initiation and viral suppression among
Augustine T Choko1,2, Thomas J Coates3, Misheck Mphande1
1Partners in Hope, Lilongwe, Malawi.
Insights
Home-based ART (hbART) improves viral suppression in men not engaged in HIV care in sub-Saharan Africa. This three-month intervention offers a promising strategy to overcome barriers to facility-based treatment and improve health outcomes for men living with HIV.
Area of Science:
- Public Health
- Infectious Diseases
- Clinical Trials
Background:
- Men in sub-Saharan Africa have twice the mortality rate on ART compared to women, often due to late HIV diagnosis and poor treatment engagement.
- Barriers to facility-based care prevent many men from initiating or adhering to antiretroviral therapy (ART).
Purpose of the Study:
- To investigate the impact of a three-month home-based ART (hbART) intervention on viral suppression among men not currently engaged in HIV care.
- To compare the effectiveness of hbART versus facility-based ART (fbART) in achieving viral suppression in this population.
Main Methods:
- An individually randomized non-blinded, non-inferiority-controlled trial (NCT04858243) in Malawi.
- Recruitment of men (≥15 years) not engaged in ART care (newly diagnosed, at risk of default, or defaulted) from high-burden facilities.
- 1:1 randomization to either 3 months of hbART (3 home visits) or fbART (facility-based care with home counseling and navigation).
Main Results:
- The primary outcome is the proportion of men virally suppressed at 6 months post-ART initiation.
- An estimated 24.0% viral suppression in the fbART arm and 33.6% in the hbART arm, with 350 men per arm for 80% power.
Conclusions:
- Effective ART strategies that are convenient and accessible for men are a priority for HIV management in sub-Saharan Africa.
- This trial focuses on a three-month hbART duration, longer than previous studies, to allow men more time to overcome barriers to ART initiation and adherence.
Background:
Men experience twice the mortality of women while on ART in sub-Saharan Africa (SSA) largely due to late HIV diagnosis and poor retention. Here we propose to conduct an individually randomized control trial (RCT) to investigate the impact of three-month home-based ART (hbART) on viral suppression among men who were not engaged in care.
Methods And Design:
A programmatic, individually randomized non-blinded, non-inferiority-controlled trial design (ClinicalTrials.org NCT04858243). Through medical chart reviews we will identify "non-engaged" men living with HIV, ≥15years of age who are not currently engaged in ART care, including (1) men who have tested HIV-positive and have not initiated ART within 7 days; (2) men who have initiated ART but are at risk of immediate default; and (3) men who have defaulted from ART. With 1:1 computer block randomization to either hbART or facility-based ART (fbART) arms, we will recruit men from 10-15 high-burden health facilities in central and southern Malawi. The hbART intervention will consist of 3 home-visits in a 3-month period by a certified male study nurse ART provider. In the fbART arm, male participants will be offered counselling at male participant's home, or a nearby location that is preferred by participants, followed with an escort to the local health facility and facility navigation. The primary outcome is the proportion of men who are virally suppressed at 6-months after ART initiation. Assuming primary outcome achievement of 24.0% and 33.6% in the two arms, 350 men per arm will provide 80% power to detect the stated difference.
Discussion:
Identifying effective ART strategies that are convenient and accessible for men in SSA is a priority in the HIV world. Men may not (re-)engage in facility-based care due to a myriad of barriers. Two previous trials investigated the impact of hbART on viral suppression in the general population whereas this trial focuses on men. Additionally, this trial involves a longer duration of hbART i.e., three months compared to two weeks allowing men more time to overcome the initial psychological denial of taking ART.
