Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho (DoDoPi)
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|ClinicalTrials.gov Identifier: NCT01459120|
Recruitment Status : Completed
First Posted : October 25, 2011
Last Update Posted : February 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Tuberculosis Diabetes Mellitus Arterial Hypertension||Other: Door-to-door Other: Pitso||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Health care workers propose the integrated service package including VCT at the peoples' homes.
Health workers propose the integrated service package including VCT at the peoples' homes (home-based testing).
Active Comparator: Pitso
Health care workers propose the integrated service package including VCT through community gatherings ("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.
- Proportion of newly tested HIV-positive clients over all clients tested for HIV during the campaignsProportion 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 [ Time Frame: 4 weeks after tested positive ]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.
- Overall number newly tested HIV-positive and enrolled into chronic HIV/AIDS-care at each facility [ Time Frame: 4 weeks after campaign ]
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.
- Absolute number of newly tested HIV-positive clientsRefers 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 [ Time Frame: 4 weeks after tested HIV-positive ]This refers to the absolute number newly tested HIV-positive during the campaigns who enrolled thereafter into chronic HIV/AIDS care within one month
- CD4-count among clients newly tested HIV-positiveCD4-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 campaignsAll 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 [ Time Frame: 5 days after the campaign was held ]Tuberculosis-suspect registers and tuberculosis registers at the facility are used for verification
- 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 ]Tuberculosis suspect registers and Tuberculosis registers at the facility are used for verification.
- 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 [ Time Frame: ≤ 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. [ Time Frame: ≤ 5 days after the campaign ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459120
|Seboche, Botha-Bothe, Lesotho, P.O. 304|
|Principal Investigator:||Motlomelo Masetsibi||SolidarMed|
|Study Director:||Niklaus Labhardt, MD, MIH||SolidarMed|
|Study Chair:||Karolin Pfeiffer, MD, McommH||SolidarMed|