HIV
Conditions
Keywords
HIV, AIDS, Antiretroviral therapy, Community-based study, Cluster-randomised trial, HIV testing, Africa
Brief summary
Despite increasing availability of antiretroviral therapy (ART) for HIV in high prevalence countries, the majority of people with HIV infection still initiate treatment at an advanced stage of disease. This leads to a high risk of death soon after HIV diagnosis. Prompt HIV diagnosis is, therefore, necessary for both individual and public health benefit and is being strongly promoted as international and national policy in Malawi. However timely HIV diagnosis may not in itself be sufficient to ensure ART initiation: this is reflected by the relatively high proportion of individuals who defer treatment-seeking for months or years following diagnosis of HIV. Here the researchers investigate the extent to which home assessment and initiation of ART adds to the effectiveness of a home-based HIV testing and counseling strategy, using entry to, adherence with, and retention in HIV care as the outcome of interest.
Interventions
OTHERHome assessment and initiation of ART
Home-based ART eligibility assessment (WHO staging, CD4 count measurement and educational treatment preparation) and initiation.
OTHERClinic-based ART assessment and initiation
Participants who meet eligibility criteria and reside in a cluster that has been allocated to the control arm of this study will receive supported access to ART care through the primary care system for confirmation of HIV status and entry into HIV following disclosure to the resident community counsellor.
Sponsors
Kamuzu University of Health Sciences
London School of Hygiene and Tropical Medicine
Ministry of Health and Population, Malawi
Liverpool School of Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Usual resident of an eligible cluster * Has had a positive HIV test (regardless of source) and requests facilitated access to HIV care from the resident community counsellor * Confirmatory HIV test is positive * No previous ART treatment, or less than one month's treatment in the past (including PMTCT interventions) and not currently receiving HIV care * No contraindications to receiving ART (as defined by Integrated Management of Adult Illnesses, HIV Department, WHO) * No acute danger signs requiring hospital referral * Aged 18 years or older * Written or witnessed informed consent to participate in the study
Exclusion criteria
* Not a usual resident of an eligible cluster * No previous HIV test, or HIV infection not confirmed by home-based ART nurse * Already receiving ART, or has had more than 1 month's treatment in the past * Known contraindication to firstline ART (known hypersensitivity, renal failure, chronic liver disease) * Acute danger sign present (as defined by Integrated Management of Adult Illnesses, HIV Department, WHO) * Age younger than 18 years * Not willing to accept home-based ART initiation * Suspected or confirmed TB disease will not be an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ART Initiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of Home-based HIV Testing | 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. |
| Reporting of HIV-positive Results | 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 |
| Loss to Retention | 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 |
| Adherence to ART | 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 |
| Adult Mortality | 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 |
Countries
Malawi
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Home Assessment and Initiation of ART 8194 adults resident in 3213 households | 8,194 |
| Clinic-based ART Assessment and Initiation 8466 adults resident in 3397 households | 8,466 |
| Total | 16,660 |
Baseline characteristics
| Characteristic | Home Assessment and Initiation of ART | Clinic-based ART Assessment and Initiation | Total |
|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 11.8 | 30.2 years STANDARD_DEVIATION 11.4 | 30.3 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 3942 Participants | 4067 Participants | 8009 Participants |
| Sex: Female, Male Male | 4252 Participants | 4399 Participants | 8651 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8,194 | 0 / 8,466 |
| serious Total, serious adverse events | 0 / 8,194 | 0 / 8,466 |
Outcome results
Primary
ART Initiation
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.
Time frame: First six months following introduction of home-based HIV testing
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Assessment and Initiation of ART | ART Initiation | 181 participants |
| Clinic-based ART Assessment and Initiation | ART Initiation | 63 participants |
Secondary
Adherence to ART
Comparison between study arms of the proportion of HIV-positive participants who are adherent to ART during the 1-year study period
Time frame: First 6-months following availability of home-based HIV testing
Secondary
Adult Mortality
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
Time frame: The first 6-months following availability of home-based HIV testing
Secondary
Loss to Retention
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
Time frame: The first 6-months following availability of home-based HIV testing
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Assessment and Initiation of ART | Loss to Retention | 52 participants |
| Clinic-based ART Assessment and Initiation | Loss to Retention | 15 participants |
Secondary
Reporting of HIV-positive Results
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
Time frame: The first 6-months following availability of home-based HIV testing
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Assessment and Initiation of ART | Reporting of HIV-positive Results | 490 participants |
| Clinic-based ART Assessment and Initiation | Reporting of HIV-positive Results | 278 participants |
Secondary
Uptake of Home-based HIV Testing
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.
Time frame: The first 6-months following home assessment and initiation of ART being made available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Assessment and Initiation of ART | Uptake of Home-based HIV Testing | 5287 participants |
| Clinic-based ART Assessment and Initiation | Uptake of Home-based HIV Testing | 4433 participants |