Clinical trial NCT01459120: Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Tuberculosis
Diabetes Mellitus
Arterial Hypertension
Keywords: Home-based HIV-testing
Voluntary Counseling and Testing
Community based testing
HIV/AIDS
Lesotho
Lead sponsor: SolidarMed
Sponsor class: OTHER
Collaborators: name: Paray Mission Hospital, Thaba-Tseka
name: Seboche Hospital, Botha-Bothe
First posted: 2011-10-25
Enrollment: 1800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of newly tested HIV-positive clients over all clients tested for HIV during the campaigns
measure: 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
timeFrame: 4 weeks after tested positive
measure: Overall number newly tested HIV-positive and enrolled into chronic HIV/AIDS-care at each facility
timeFrame: 4 weeks after campaign
measure: Absolute number of newly tested HIV-positive clients
measure: Absolute number of clients newly tested HIV-positive who enrolled into HIV/AIDS care
timeFrame: 4 weeks after tested HIV-positive
Secondary outcomes:
measure: CD4-count among clients newly tested HIV-positive
measure: Clinical WHO-stage among clients newly tested HIV-positive
measure: Proportion of clients screened positive for Tuberculosis during the campaigns
measure: Proportion of first-time HIV-testers among all clients accessing the testing services
measure: Proportion of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility
timeFrame: 5 days after the campaign was held
measure: Proportion of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
timeFrame: 5 days after the campaign was held
measure: Demographic characteristics of clients accessing the voluntary counseling and testing services
measure: Absolute number of clients accessing the services at the campaigns who have a positive screening for Tuberculosis
measure: Absolute number of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility
timeFrame: ≤ 5 days after the campaigns
measure: Absolute number of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
timeFrame: ≤ 5 days after the campaign
Other outcomes:
Locations:
city: Seboche
country: Lesotho
facility: Seboche Hospital
state: Botha-Bothe
city: Thaba-Tseka
country: Lesotho
facility: Paray Hospital
Study officials:
affiliation: SolidarMed
name: Motlomelo Masetsibi
role: PRINCIPAL_INVESTIGATOR
affiliation: SolidarMed
name: Niklaus Labhardt, MD, MIH
role: STUDY_DIRECTOR
affiliation: SolidarMed
name: Karolin Pfeiffer, MD, McommH
role: STUDY_CHAIR
References:
citation: Labhardt ND, Motlomelo M, Cerutti B, Pfeiffer K, Kamele M, Hobbins MA, Ehmer J. Home-based versus mobile clinic HIV testing and counseling in rural Lesotho: a cluster-randomized trial. PLoS Med. 2014 Dec 16;11(12):e1001768. doi: 10.1371/journal.pmed.1001768. eCollection 2014 Dec.