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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Village-based vs Clinic-based ART Care - a Cluster Randomized Controlled Trial in Lesotho

NCT03630549

HIV/AIDS

COMPLETED PHASE4

Same-day ART Initiation Versus Standard of Care After Positive HIV-test Result in Rural Lesotho

NCT02692027

HIV Infection

COMPLETED PHASE3

Viral Load Triggered ART Care in Lesotho

NCT04527874

HIV Infections

COMPLETED NA

Enhanced HIV Prevention in Couples: Feasibility Study #3

NCT02027519

Human Immunodeficiency Virus (HIV) Acquired Immune Deficiency Syndrome (AIDS)

COMPLETED

HOme-based SElf-testiNG - a Cluster Randomized Controlled Trial in Rural Lesotho (HOSENG)

NCT03598686

HIV HIV/AIDS

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV/AIDS Tuberculosis Diabetes Mellitus Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Door-to-Door

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

Group Type EXPERIMENTAL

Door-to-door

Intervention Type OTHER

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

Pitso

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

Group Type ACTIVE_COMPARATOR

Pitso

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Door-to-door

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

Intervention Type OTHER

Pitso

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes