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

8. Februar 2012 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

1800

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Door-to-Door
Health care workers propose the integrated service package including VCT at the peoples' homes.
Sonstiges: Door-to-door
Health workers propose the integrated service package including VCT at the peoples' homes (home-based testing).
Aktiver Komparator: Pitso
Health care workers propose the integrated service package including VCT through community gatherings ("pitso").
Sonstiges: Pitso
Health care workers propose the integrated service package including VCT through community gatherings ("Pitso").
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: ≤ 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.
Zeitfenster: ≤ 5 days after the campaign
≤ 5 days after the campaign

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

SolidarMed

Mitarbeiter

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

Ermittler

  • Hauptermittler: Motlomelo Masetsibi, SolidarMed
  • Studienleiter: Niklaus Labhardt, MD, MIH, SolidarMed
  • Studienstuhl: Karolin Pfeiffer, MD, McommH, SolidarMed

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2011

Primärer Abschluss (Tatsächlich)

1. Februar 2012

Studienabschluss (Tatsächlich)

1. Februar 2012

Studienanmeldedaten

Zuerst eingereicht

18. Oktober 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Oktober 2011

Zuerst gepostet (Schätzen)

25. Oktober 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

9. Februar 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Februar 2012

Zuletzt verifiziert

1. Februar 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DoDoPi-1

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