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Completed

NCT Number: NCT01459120

Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services 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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Actinomycetales Infections Arterial Hypertension Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Diabetes Mellitus Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders Gram-Positive Bacterial Infections HIV Infections Hypertension Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Mycobacterium Infections Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Urogenital Diseases Vascular Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seboche Hospital, Seboche, Botha-Bothe, Lesotho

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Door-to-door

Other

Health workers propose the integrated service package including VCT at the peoples' homes (home-based testing).

Pitso

Other

Health care workers propose the integrated service package including VCT through community gatherings ("Pitso").

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Absolute number of newly tested HIV-positive clients

    Refers to the overall number newly tested HIV-positive during the campaigns in both arms

  5. 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

Secondary outcomes

  1. CD4-count among clients newly tested HIV-positive

    CD4-counts will be measured on site using a Point-of-care machine.

  2. Clinical WHO-stage among clients newly tested HIV-positive

  3. 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.

  4. Proportion of first-time HIV-testers among all clients accessing the testing services

  5. 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

  6. 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.

  7. Demographic characteristics of clients accessing the voluntary counseling and testing services

  8. Absolute number of clients accessing the services at the campaigns who have a positive screening for Tuberculosis

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

SolidarMed

Other

Collaborators

  • Paray Mission Hospital, Thaba-Tseka
  • Seboche Hospital, Botha-Bothe

Registry information

Official study 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

Acronym: DoDoPi

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2011
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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