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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
Sponsor:
Collaborators:
Paray Mission Hospital, Thaba-Tseka
Seboche Hospital, Botha-Bothe
Information provided by (Responsible Party):
Niklaus Labhardt, SolidarMed

Tracking Information
First Submitted Date  ICMJE October 18, 2011
First Posted Date  ICMJE October 25, 2011
Last Update Posted Date February 9, 2012
Study Start Date  ICMJE October 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2011)
  • 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.
  • 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:
    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
    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 ]
    This refers to the absolute number newly tested HIV-positive during the campaigns who enrolled thereafter into chronic HIV/AIDS care within one month
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2011)
  • CD4-count among clients newly tested HIV-positive
    CD4-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 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.
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho
Official Title  ICMJE 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
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • HIV/AIDS
  • Tuberculosis
  • Diabetes Mellitus
  • Arterial Hypertension
Intervention  ICMJE
  • 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").
Study Arms  ICMJE
  • 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.
Publications * Labhardt ND, Motlomelo M, Cerutti B, Pfeiffer K, Kamele M, Hobbins MA, Ehmer J. Home-based versus mobile clinic HIV testing and counseling in rural Lesotho: a cluster-randomized trial. PLoS Med. 2014 Dec 16;11(12):e1001768. doi: 10.1371/journal.pmed.1001768. eCollection 2014 Dec.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 21, 2011)
1800
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Lesotho
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01459120
Other Study ID Numbers  ICMJE DoDoPi-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Niklaus Labhardt, SolidarMed
Study Sponsor  ICMJE SolidarMed
Collaborators  ICMJE
  • Paray Mission Hospital, Thaba-Tseka
  • Seboche Hospital, Botha-Bothe
Investigators  ICMJE
Principal Investigator: Motlomelo Masetsibi SolidarMed
Study Director: Niklaus Labhardt, MD, MIH SolidarMed
Study Chair: Karolin Pfeiffer, MD, McommH SolidarMed
PRS Account SolidarMed
Verification Date February 2012

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