Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho (DoDoPi)

SolidarMed

Status: Completed

Conditions: Tuberculosis; Arterial Hypertension; Diabetes Mellitus; HIV/AIDS

Treatments: Other: Pitso; Other: Door-to-door

Study type: Interventional

Funder types: Other

Identifiers

NCT01459120

DoDoPi-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,800 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,800 participants in 3 patient groups

Door-to-Door

Experimental group

Description:

Health care workers propose the integrated service package including VCT at the peoples' homes.

Treatment:

Other: Door-to-door

Pitso

Active Comparator group

Description:

Health care workers propose the integrated service package including VCT through community gatherings ("pitso").

Treatment:

Other: Pitso

control

No Intervention group

Description:

Within each cluster (catchment area of a health center), five villages are randomly chosen as comparators on cluster level. These villages get no particular intervention (VCT-campaign). However, routine services continue to be provided. These villages serve as a control for the third primary outcome that assesses the overall numbers newly enrolled into chronic HIV/AIDS care at facility-level.