Brief Summary

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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"

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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
• Study Primary Completion Date: February 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

• Other: Door-to-door
  • Health workers propose the integrated service package including VCT at the peoples' homes (home-based testing).
• Other: Pitso
  • Health care workers propose the integrated service package including VCT through community gatherings ("Pitso").

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Door-to-Door
  • Health care workers propose the integrated service package including VCT at the peoples' homes.
• Active Comparator: Pitso
  • Health care workers propose the integrated service package including VCT through community gatherings ("pitso").
• No Intervention: control
  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

• Proportion of newly tested HIV-positive clients over all clients tested for HIV during the campaigns
  • Safety Issue?: No
• 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
    Safety Issue?: No
• Overall number newly tested HIV-positive and enrolled into chronic HIV/AIDS-care at each facility
  • Time Frame: 4 weeks after campaign
    Safety Issue?: No
• Absolute number of newly tested HIV-positive clients
  • Safety Issue?: No
• Absolute number of clients newly tested HIV-positive who enrolled into HIV/AIDS care
  • Time Frame: 4 weeks after tested HIV-positive
    Safety Issue?: No

Secondary Measures

• CD4-count among clients newly tested HIV-positive
  • Safety Issue?: No
• Clinical WHO-stage among clients newly tested HIV-positive
  • Safety Issue?: No
• Proportion of clients screened positive for Tuberculosis during the campaigns
  • Safety Issue?: No
• Proportion of first-time HIV-testers among all clients accessing the testing services
  • Safety Issue?: No
• Proportion of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility
  • Time Frame: 5 days after the campaign was held
    Safety Issue?: No
• Proportion of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
  • Time Frame: 5 days after the campaign was held
    Safety Issue?: No
• Demographic characteristics of clients accessing the voluntary counseling and testing services
  • Safety Issue?: No
• Absolute number of clients accessing the services at the campaigns who have a positive screening for Tuberculosis
  • Safety Issue?: No
• Absolute number of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility
  • Time Frame: ≤ 5 days after the campaigns
    Safety Issue?: No
• Absolute number of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
  • Time Frame: ≤ 5 days after the campaign
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

• Lead Sponsor
  • SolidarMed
• Collaborator
  • Paray Mission Hospital, Thaba-Tseka
• Provider of Information About this Clinical Study
  • Principal Investigator: Niklaus Labhardt, Project Manager - SolidarMed
• Overall Official(s)
  • Motlomelo Masetsibi, Principal Investigator, SolidarMed
  • Niklaus Labhardt, MD, MIH, Study Director, SolidarMed
  • Karolin Pfeiffer, MD, McommH, Study Chair, SolidarMed