Trial Outcomes & Findings for Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi (NCT NCT01414413)

Results Overview

Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16660 participants

Primary outcome timeframe

First six months following introduction of home-based HIV testing

Results posted on

2014-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Home Assessment and Initiation of ART Optional home initiation of HIV care following HIV self-testing	Clinic-based ART Assessment and Initiation Facility-based HIV care following HIV self-testing only
Overall Study STARTED	8194	8466
Overall Study COMPLETED	8194	8466
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home Assessment and Initiation of ART n=8194 Participants 8194 adults resident in 3213 households	Clinic-based ART Assessment and Initiation n=8466 Participants 8466 adults resident in 3397 households	Total n=16660 Participants Total of all reporting groups
Age, Continuous	30.4 years STANDARD_DEVIATION 11.8 • n=5 Participants	30.2 years STANDARD_DEVIATION 11.4 • n=7 Participants	30.3 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	3942 Participants n=5 Participants	4067 Participants n=7 Participants	8009 Participants n=5 Participants
Sex: Female, Male Male	4252 Participants n=5 Participants	4399 Participants n=7 Participants	8651 Participants n=5 Participants

PRIMARY outcome

Timeframe: First six months following introduction of home-based HIV testing

Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention.

Outcome measures

Outcome measures
Measure	Home Assessment and Initiation of ART n=8194 Participants Optional home initiation of HIV care following HIV self-testing	Clinic-based ART Assessment and Initiation n=8466 Participants Facility-based HIV care following HIV self-testing only
ART Initiation	181 participants	63 participants

SECONDARY outcome

Timeframe: The first 6-months following home assessment and initiation of ART being made available

Comparison between study arms of the proportion of all resident adults who request HIV testing (either as standard HTC or as supervised HIV self-testing) from the resident community counsellor during the first year of the study.

Outcome measures

Outcome measures
Measure	Home Assessment and Initiation of ART n=8194 Participants Optional home initiation of HIV care following HIV self-testing	Clinic-based ART Assessment and Initiation n=8466 Participants Facility-based HIV care following HIV self-testing only
Uptake of Home-based HIV Testing	5287 participants	4433 participants

SECONDARY outcome

Timeframe: The first 6-months following availability of home-based HIV testing

Comparison of the proportion of all cluster adults confiding HIV-positive results to the resident community counsellor between study arms during the 1-year study period

Outcome measures

Outcome measures
Measure	Home Assessment and Initiation of ART n=8194 Participants Optional home initiation of HIV care following HIV self-testing	Clinic-based ART Assessment and Initiation n=8466 Participants Facility-based HIV care following HIV self-testing only
Reporting of HIV-positive Results	490 participants	278 participants

SECONDARY outcome

Timeframe: The first 6-months following availability of home-based HIV testing

Comparison between study arms of the proportion of participants who initiate ART during the first 6-months of the HIV-testing intervention who are lost to retention within 6 months after initiating ART 6-months

Outcome measures

Outcome measures
Measure	Home Assessment and Initiation of ART n=181 Participants Optional home initiation of HIV care following HIV self-testing	Clinic-based ART Assessment and Initiation n=63 Participants Facility-based HIV care following HIV self-testing only
Loss to Retention	52 participants	15 participants

SECONDARY outcome

Timeframe: First 6-months following availability of home-based HIV testing

Comparison between study arms of the proportion of HIV-positive participants who are adherent to ART during the 1-year study period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The first 6-months following availability of home-based HIV testing

Comparison between study arms of non-traumatic and HIV-related adult (15-49) mortality rates during the first 6 months of the HIV-testing intervention

Outcome measures

Outcome data not reported

Adverse Events

Home Assessment and Initiation of ART

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clinic-based ART Assessment and Initiation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Peter MacPherson

Liverpool School of Tropical Medicine

Phone: 0044151 705 3100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place