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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01459120
Other study ID # DoDoPi-1
Secondary ID
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


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
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