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

This study has been completed.
Sponsor:
Collaborators:
Paray Mission Hospital, Thaba-Tseka
Seboche Hospital, Botha-Bothe
Information provided by (Responsible Party):
Niklaus Labhardt, SolidarMed
ClinicalTrials.gov Identifier:
NCT01459120
First received: October 18, 2011
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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

Resource links provided by NLM:


Further study details as provided by SolidarMed:

Primary Outcome Measures:
  • 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:

    1. 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)
    2. 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


Secondary Outcome Measures:
  • 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459120

Locations
Lesotho
Seboche Hospital
Seboche, Botha-Bothe, Lesotho, P.O. 304
Paray Hospital
Thaba-Tseka, Lesotho
Sponsors and Collaborators
SolidarMed
Paray Mission Hospital, Thaba-Tseka
Seboche Hospital, Botha-Bothe
Investigators
Principal Investigator: Motlomelo Masetsibi SolidarMed
Study Director: Niklaus Labhardt, MD, MIH SolidarMed
Study Chair: Karolin Pfeiffer, MD, McommH SolidarMed
  More Information

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:
Diabetes Mellitus
Hypertension
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Gram-Positive Bacterial Infections
Metabolic Diseases
Mycobacterium Infections
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014