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

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.

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

Conditions
-----------------
HIV/AIDS, Tuberculosis, Diabetes Mellitus, Arterial Hypertension

Intervention / Treatment
-----------------
* Other: Door-to-door
* Other: Pitso


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Door-to-Door<br>Health care workers propose the integrated service package including VCT at the peoples' homes. | Other: Door-to-door<br>* Health workers propose the integrated service package including VCT at the peoples' homes (home-based testing).<br>|
| Active Comparator: Pitso<br>Health care workers propose the integrated service package including VCT through community gatherings (pitso). | Other: Pitso<br>* Health care workers propose the integrated service package including VCT through community gatherings (Pitso).<br>|
| No Intervention: control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 4 weeks after tested positive | 
| Overall number newly tested HIV-positive and enrolled into chronic HIV/AIDS-care at each facility | Between the two study-arms, the overall numbers will be compared in two ways: 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) 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. | 4 weeks after campaign | 
| 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 | This refers to the absolute number newly tested HIV-positive during the campaigns who enrolled thereafter into chronic HIV/AIDS care within one month | 4 weeks after tested HIV-positive | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4-count among clients newly tested HIV-positive | CD4-counts will be measured on site using a Point-of-care machine. |  | 
| Clinical WHO-stage among clients newly tested HIV-positive |  |  | 
| Proportion of clients screened positive for Tuberculosis during the campaigns | All clients accessing services (irrespective of HIV-status) will be screened for TB by a nurse. Clients with a positive screening are provided sputum bottles and are entered in the Tuberculosis-suspect register. |  | 
| 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 | Tuberculosis-suspect registers and tuberculosis registers at the facility are used for verification | 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. | Tuberculosis suspect registers and Tuberculosis registers at the facility are used for verification. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Home-based HIV-testing, Voluntary Counseling and Testing, Community based testing, HIV/AIDS, Lesotho