Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho (DoDoPi)
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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.
Condition | Intervention |
---|---|
HIV/AIDS Tuberculosis Diabetes Mellitus Arterial Hypertension |
Other: Door-to-door Other: Pitso |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- Proportion of newly tested HIV-positive clients over all clients tested for HIV during the campaigns [ Designated as safety issue: No ]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 [ Time Frame: 4 weeks after tested positive ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 clients [ Designated as safety issue: No ]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 [ Time Frame: 4 weeks after tested HIV-positive ] [ Designated as safety issue: No ]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-positive [ Designated as safety issue: No ]CD4-counts will be measured on site using a Point-of-care machine.
- Clinical WHO-stage among clients newly tested HIV-positive [ Designated as safety issue: No ]
- Proportion of clients screened positive for Tuberculosis during the campaigns [ Designated as safety issue: No ]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 [ Designated as 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Tuberculosis suspect registers and Tuberculosis registers at the facility are used for verification.
- Demographic characteristics of clients accessing the voluntary counseling and testing services [ Designated as safety issue: No ]
- Absolute number of clients accessing the services at the campaigns who have a positive screening for Tuberculosis [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
Estimated Enrollment: | 1800 |
Study Start Date: | October 2011 |
Study Completion Date: | February 2012 |
Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Door-to-Door
Health care workers propose the integrated service package including VCT at the peoples' homes.
|
Other: Door-to-door
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").
|
Other: 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.
|
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.
![](https://webarchive.library.unt.edu/web/20130305101344im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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
![](https://webarchive.library.unt.edu/web/20130305101344im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Lesotho | |
Seboche Hospital | |
Seboche, Botha-Bothe, Lesotho, P.O. 304 | |
Paray Hospital | |
Thaba-Tseka, Lesotho |
Principal Investigator: | Motlomelo Masetsibi | SolidarMed |
Study Director: | Niklaus Labhardt, MD, MIH | SolidarMed |
Study Chair: | Karolin Pfeiffer, MD, McommH | SolidarMed |
![](https://webarchive.library.unt.edu/web/20130305101344im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Niklaus Labhardt, Project Manager, SolidarMed |
ClinicalTrials.gov Identifier: | NCT01459120 History of Changes |
Other Study ID Numbers: | DoDoPi-1 |
Study First Received: | October 18, 2011 |
Last Updated: | February 8, 2012 |
Health Authority: | Lesotho: Ministry of Health and Social Welfare |
Keywords provided by SolidarMed:
Home-based HIV-testing Voluntary Counseling and Testing Community based testing HIV/AIDS Lesotho |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome Diabetes Mellitus Hypertension Tuberculosis HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on March 03, 2013