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

October 18, 2011
February 8, 2012
October 2011
February 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01459120 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV/AIDS
  • Tuberculosis
  • Diabetes Mellitus
  • Arterial Hypertension
  • Other: Door-to-door
    Health workers propose the integrated service package including VCT at the peoples' homes (home-based testing).
  • Other: Pitso
    Health care workers propose the integrated service package including VCT through community gatherings ("Pitso").
  • Experimental: Door-to-Door
    Health care workers propose the integrated service package including VCT at the peoples' homes.
    Intervention: Other: Door-to-door
  • Active Comparator: Pitso
    Health care workers propose the integrated service package including VCT through community gatherings ("pitso").
    Intervention: Other: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1800
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Lesotho
 
NCT01459120
DoDoPi-1
No
Niklaus Labhardt, SolidarMed
SolidarMed
  • Paray Mission Hospital, Thaba-Tseka
  • Seboche Hospital, Botha-Bothe
Principal Investigator: Motlomelo Masetsibi SolidarMed
Study Director: Niklaus Labhardt, MD, MIH SolidarMed
Study Chair: Karolin Pfeiffer, MD, McommH SolidarMed
SolidarMed
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP