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| ID | Type | Description | Link |
|---|---|---|---|
| WT089673/B/09/Z | Other Grant/Funding Number | Wellcome Trust, UK |
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| Name | Class |
|---|---|
| Kamuzu University of Health Sciences | OTHER |
| London School of Hygiene and Tropical Medicine | OTHER |
| Ministry of Health, Malawi | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home assessment and initiation of ART | Experimental | Participants with a positive home-based HIV test result will receive a home visit from a study nurse who will complete the following on the first home visit:
At a second home visit (within 5 days), participants who are ART eligible (as defined in National ART guidelines) will be initiated onto ART (using National Treatment Programme ART regimens). Following home initiation of ART, participants in the intervention arm will receive detailed counselling from the study nurse about the need to attend their first 2-week follow-up appointment at the primary health care clinic that serves their household's residence. They will receive a referral slip detailing the date, time and place of their appointment. |
|
| Clinic-based ART assessment and initiation | Other | 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. HIV care, including ART, will be started from the primary care clinic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home assessment and initiation of ART | Other | Home-based ART eligibility assessment (WHO staging, CD4 count measurement and educational treatment preparation) and initiation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First six months following introduction of home-based HIV testing |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The first 6-months following home assessment and initiation of ART being made available |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter MacPherson, MBChCB MPH | Liverpool School of Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malawi-Liverpool-Wellcome Trust Clinical Research Programme | Blantyre | Chichiri | 3 | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25038356 | Derived | MacPherson P, Lalloo DG, Webb EL, Maheswaran H, Choko AT, Makombe SD, Butterworth AE, van Oosterhout JJ, Desmond N, Thindwa D, Squire SB, Hayes RJ, Corbett EL. Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial. JAMA. 2014 Jul 23-30;312(4):372-9. doi: 10.1001/jama.2014.6493. |
| Label | URL |
|---|---|
| Liverpool School of Tropical Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home Assessment and Initiation of ART | Optional home initiation of HIV care following HIV self-testing |
| FG001 | Clinic-based ART Assessment and Initiation | Facility-based HIV care following HIV self-testing only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The 14 clusters included in the study had a combined adult population of 16660, with 8194 adults resident in 3213 households in the OHC arm and 8466 adults resident in 3397 households in the FCO arm. Socio-demographic characteristics assessed in the baseline enumeration were well balanced between intervention groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Home Assessment and Initiation of ART | 8194 adults resident in 3213 households |
| BG001 | Clinic-based ART Assessment and Initiation | 8466 adults resident in 3397 households |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | First six months following introduction of home-based HIV testing |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home Assessment and Initiation of ART | Optional home initiation of HIV care following HIV self-testing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Peter MacPherson | Liverpool School of Tropical Medicine | 0044151 705 3100 | p.macpherson@liv.ac.uk |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Clinic-based ART assessment and initiation | Other | 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. |
|
| 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 | The first 6-months following availability of home-based HIV testing |
| 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 | The first 6-months following availability of home-based HIV testing |
| 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 | First 6-months following availability of home-based HIV testing |
| 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 | The first 6-months following availability of home-based HIV testing |
| Wellcome Trust | View source |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| 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. | Posted | Number | participants | The first 6-months following home assessment and initiation of ART being made available |
|
|
|
| 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 | Posted | Number | participants | 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 | Posted | Number | participants | The first 6-months following availability of home-based HIV testing |
|
|
|
| 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 | Not Posted | 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 | Not Posted | The first 6-months following availability of home-based HIV testing |
| 0 |
| 8,194 |
| 0 |
| 8,194 |
| EG001 | Clinic-based ART Assessment and Initiation | Facility-based HIV care following HIV self-testing only | 0 | 8,466 | 0 | 8,466 |
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| 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 |