Comparing Door-to-door Versus Community Gathering in Providing HIV Counseling and Testing Within an Integrated Primary Health Care Package: a Cluster Randomized Trial in Rural Lesotho
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- SolidarMed
- Enrollment
- 1,800
- Locations
- 3
- Primary Endpoint
- Proportion of newly tested HIV-positive clients over all clients tested for HIV during the campaigns
Study Overview
Brief Summary
The purpose of this trial is to determine if door-to-door is more effective than community gathering in providing voluntary HIV counseling and testing (VCT) in communities in rural Lesotho. The voluntary HIV counseling and testing will be proposed as an integrated part of a package of proposed services. The package consists of: Blood-pressure measurement, blood-glucose measurement, Body-mass-index (adults), weight for height (children), catch-up vaccinations, deworming (children) Vitamin A (children & young women), family planning for eligible women, Tuberculosis screening and HIV counseling and testing.
Detailed Description
12 health centers (clusters) in rural Lesotho are matched according to their routine performance in VCT and enrollment into chronic HIV/AIDS care (average numbers tested positive and enrolled into HIV/AIDS care per month per facility). After matching, 6 health centers are randomly assigned to perform door-to-door VCT, whereas the others perform the traditional community gathering approach (called "pitso" in Sesotho). Within the catchment area of each health center five campaigns in five different, randomly selected villages, are held (one day VCT campaign per village). Within each cluster another five villages are randomly selected who do not get a particular campaign and serve as a control for each cluster. In each matched cluster-pair, both health centers conduct the five campaigns during the same week (one conducting it as door-to-door, the other one conducting it through "pitsos" (community gathering)).
Both approaches receive the same resources in terms of finances, time spending doing the VCT-campaign and human resources.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Not already known to be HIV-positive
- •Resident in the catchment area of the health center where the campaign is conducted
- •Provision of written informed consent to participate (signed by writing or fingerprint)
- •In case of children: Provision of written informed consent by an adult care-taker
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of newly tested HIV-positive clients over all clients tested for HIV during the campaigns
Proportion refers to the proportion of newly tested HIV-positive clients among all clients tested for HIV during the voluntary counselling and testing campaigns in each arm.
Proportion of clients newly tested HIV-positive who enrolled into HIV/AIDS care within one month over all clients newly tested HIV-positive during the campaigns
Time Frame: 4 weeks after tested positive
One month after the campaigns, enrollment of clients who newly tested HIV-positive at the campaign is assessed at the facilities based on the clinics' registers.
Overall number newly tested HIV-positive and enrolled into chronic HIV/AIDS-care at each facility
Time Frame: 4 weeks after campaign
Between the two study-arms, the overall numbers will be compared in two ways: 1. Total number positively tested and enrolled into care at the facility during the month after the campaign (this refers to the overall number at facility-level. Irrespective if these patients were tested during one of the campaigns or during routine activities at the facility) 2. Total number positively tested and enrolled into care from the 5 villages where campaigns were held as compared to the five villages where no campaigns were held.
Absolute number of newly tested HIV-positive clients
Refers to the overall number newly tested HIV-positive during the campaigns in both arms
Absolute number of clients newly tested HIV-positive who enrolled into HIV/AIDS care
Time Frame: 4 weeks after tested HIV-positive
This refers to the absolute number newly tested HIV-positive during the campaigns who enrolled thereafter into chronic HIV/AIDS care within one month
Secondary Outcomes
- CD4-count among clients newly tested HIV-positive
- Clinical WHO-stage among clients newly tested HIV-positive
- Proportion of clients screened positive for Tuberculosis during the campaigns
- Proportion of first-time HIV-testers among all clients accessing the testing services
- Proportion of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility(5 days after the campaign was held)
- Proportion of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.(5 days after the campaign was held)
- Demographic characteristics of clients accessing the voluntary counseling and testing services
- Absolute number of clients accessing the services at the campaigns who have a positive screening for Tuberculosis
- Absolute number of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility(≤ 5 days after the campaigns)
- Absolute number of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.(≤ 5 days after the campaign)
Investigators
Niklaus Labhardt
Project Manager
SolidarMed