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

8 februari 2012 bijgewerkt door: Niklaus Labhardt, SolidarMed

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

1800

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Lesotho
      • Thaba-Tseka, Lesotho
        • Paray Hospital
    • Botha-Bothe
      • Seboche, Botha-Bothe, Lesotho, P.O. 304
        • Seboche Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Door-to-Door
Health care workers propose the integrated service package including VCT at the peoples' homes.
Ander: Door-to-door
Health workers propose the integrated service package including VCT at the peoples' homes (home-based testing).
Actieve vergelijker: Pitso
Health care workers propose the integrated service package including VCT through community gatherings ("pitso").
Ander: Pitso
Health care workers propose the integrated service package including VCT through community gatherings ("Pitso").
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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.
4 weeks after tested positive
Overall number newly tested HIV-positive and enrolled into chronic HIV/AIDS-care at each facility
Tijdsspanne: 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.
4 weeks after campaign
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
Tijdsspanne: 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
4 weeks after tested HIV-positive

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 5 days after the campaign was held
Tuberculosis-suspect registers and tuberculosis registers at the facility are used for verification
5 days after the campaign was held
Proportion of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
Tijdsspanne: 5 days after the campaign was held
Tuberculosis suspect registers and Tuberculosis registers at the facility are used for verification.
5 days after the campaign was held
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
Tijdsspanne: ≤ 5 days after the campaigns
≤ 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.
Tijdsspanne: ≤ 5 days after the campaign
≤ 5 days after the campaign

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

SolidarMed

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Motlomelo Masetsibi, SolidarMed
  • Studie directeur: Niklaus Labhardt, MD, MIH, SolidarMed
  • Studie stoel: Karolin Pfeiffer, MD, McommH, SolidarMed

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2011

Primaire voltooiing (Werkelijk)

1 februari 2012

Studie voltooiing (Werkelijk)

1 februari 2012

Studieregistratiedata

Eerst ingediend

18 oktober 2011

Eerst ingediend dat voldeed aan de QC-criteria

21 oktober 2011

Eerst geplaatst (Schatting)

25 oktober 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

9 februari 2012

Laatste update ingediend die voldeed aan QC-criteria

8 februari 2012

Laatst geverifieerd

1 februari 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DoDoPi-1

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