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

Diabetes Mellitus Clinical Trial

— DoDoPi  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459120
• Other study ID #: DoDoPi-1
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: February 8, 2012
• Start date: October 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: SolidarMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lesotho: Ministry of Health and Social Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Arterial Hypertension
• Diabetes Mellitus
• HIV/AIDS
• Hypertension
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Lesotho	Seboche Hospital	Seboche	Botha-Bothe
Lesotho	Paray Hospital	Thaba-Tseka

Sponsors (3)

Lead Sponsor	Collaborator
SolidarMed	Paray Mission Hospital, Thaba-Tseka, Seboche Hospital, Botha-Bothe

Country where clinical trial is conducted

Lesotho, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Primary	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	No
Primary	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	No
Primary	Absolute number of newly tested HIV-positive clients	Refers to the overall number newly tested HIV-positive during the campaigns in both arms		No
Primary	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	No
Secondary	CD4-count among clients newly tested HIV-positive	CD4-counts will be measured on site using a Point-of-care machine.		No
Secondary	Clinical WHO-stage among clients newly tested HIV-positive			No
Secondary	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.		No
Secondary	Proportion of first-time HIV-testers among all clients accessing the testing services			No
Secondary	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	No
Secondary	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	No
Secondary	Demographic characteristics of clients accessing the voluntary counseling and testing services			No
Secondary	Absolute number of clients accessing the services at the campaigns who have a positive screening for Tuberculosis			No
Secondary	Absolute number of clients with positive tuberculosis screening who return 3 sputum-bottles within = 5 days to the facility		= 5 days after the campaigns	No
Secondary	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	No