NCT01459120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

October 18, 2011

Last Update Submit

February 8, 2012

Conditions

HIV/AIDSTuberculosisDiabetes MellitusArterial Hypertension

Keywords

Home-based HIV-testingVoluntary Counseling and TestingCommunity based testingHIV/AIDSLesotho

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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

    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

Secondary Outcomes (10)

  • CD4-count among clients newly tested HIV-positive

  • Clinical WHO-stage among clients newly tested HIV-positive

  • Proportion of clients screened positive for Tuberculosis during the campaigns

  • 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

    5 days after the campaign was held

  • +5 more secondary outcomes

Study Arms (3)

Door-to-Door

EXPERIMENTAL

Health care workers propose the integrated service package including VCT at the peoples' homes.

Other: Door-to-door

Pitso

ACTIVE COMPARATOR

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

Other: Pitso

control

NO INTERVENTION

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.

Interventions

Door-to-doorOTHER

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

Door-to-Door
PitsoOTHER

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

Pitso

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seboche Hospital

Seboche, Botha-Bothe, P.O. 304, Lesotho

Location

Paray Hospital

Thaba-Tseka, Thaba-Tseka, Lesotho

Location

Related Publications (1)

  • 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.

    PMID: 25513807DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeTuberculosisDiabetes MellitusHypertension

Interventions

Time-to-Treatment

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Motlomelo Masetsibi

    SolidarMed

    PRINCIPAL INVESTIGATOR

  • Niklaus Labhardt, MD, MIH

    SolidarMed

    STUDY DIRECTOR

  • Karolin Pfeiffer, MD, McommH

    SolidarMed

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 25, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

LE(2)