Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda

November 16, 2023 updated by: Susan M Kiene
The purpose of this study is to evaluate the effectiveness of a linkage to care intervention at achieving HIV viral suppression and intermediate outcomes of linkage/time to care, time to /receipt of opportunistic infection prophylaxis, and antiretroviral therapy (ART) among people testing HIV positive during home-based HIV counseling and testing (HBHCT) in rural Uganda.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Throughout sub-Saharan Africa there is a pressing need to facilitate early and easier entry into HIV care and treatment; up to two-thirds of patients are lost to follow up between testing HIV positive and initiation of antiretroviral (ARV) treatment. Home-based HIV testing and counseling (HBHCT), which identifies those who are HIV positive at earlier disease stages than other testing approaches, is becoming a large component of many sub-Saharan African countries' HIV prevention programs, including Uganda's. Paper-based referral to care, sometimes adding follow-up home visits, is the most common linkage-to-care approach with HBHCT. Linkage to care may be challenging with HBHCT since the testing occurs in the home at a distance from a health facility. The investigators propose to test an intervention which enhances a linkage to care intervention tested in an urban Ugandan provider-initiated HIV testing setting and found to improve linkage to care. The aims of the project are: (1) In a cluster randomized trial compare the effectiveness of the enhanced linkage to care intervention vs. standard-of-care (paper based referrals) at achieving HIV viral suppression and intermediate outcomes of linkage to care, receipt of opportunistic infection prophylaxis, and ART initiation among those eligible for antiretroviral therapy (ART). (2) Using the standard-of-care group as a natural history control, collect longitudinal data on barriers to and facilitators of linkage to and retention in care and treatment and HIV viral suppression. (3) Estimate the cost-effectiveness of the intervention, as compared to standard-of-care, in terms of major study outcomes.

Participation in the full study will last 12 months. All participants will first undergo HBHCT, viral load and CD4 testing, and complete a brief questionnaire. Participants will then be randomly assigned to one of two study arms: the enhanced linkage to care intervention arm or the standard-of-care control arm. Participants in both study arms will participate in interviewer administered questionnaires at 6 months and 12 months follow-up, viral load and CD4 testing at 12 month follow-up, and will permit the research team to access their medical records to extract information about their health status and linkage to care. Participants in the intervention arm will also receive a series of counseling sessions with an HIV counselor taking place at the participant's home, clinic, and over the phone. These sessions will last approximately 30 minutes, and consist of counseling to help clients identify and reduce barriers to engagement in care, assistance disclosing and identifying a treatment supporter, and stigma reduction through increasing social support.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
567

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Gombe, Uganda
        • Butambala, Mpigi, Mityana, Gomba Districts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion/Exclusion for home-based HIV counseling and testing and brief baseline questionnaire:

Inclusion Criteria:

• 18-59 years of age or an emancipated minor

Exclusion Criteria:

  • not a resident of the household
  • Does not speak Luganda or English

Inclusion/Exclusion for the Intervention Study:

Inclusion criteria:

  • participated in the baseline interview and home-based HIV counseling and testing,
  • newly diagnosed HIV positive in the home-based HIV counseling and testing or previously diagnosed but never linked to HIV care

Exclusion criteria:

• Other household members also newly diagnosed as HIV positive/previously diagnosed but never linked to care. Only one person per household will be eligible to enroll

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enhanced Linkage
Participants will receive the enhanced linkage to care Intervention. Behavioral: Enhanced linkage to care Intervention Multiple sessions will focus on providing orientation to the HIV care system, counseling to help clients identify and reduce barriers to engagement in care, assistance disclosing and identifying a treatment supporter, and stigma reduction through increasing social support. The approach is guided by the HIV Stigma Framework.
Behavioral: Enhanced linkage to care
Active Comparator: Standard-of-care plus
Behavioral: Participants will receive the standard-of-care (paper-based referrals) plus return of CD4 test results to their home.
Behavioral: Standard-of-care plus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Undetectable HIV Viral load
Time Frame: 12 months follow up
defined as HIV RNA <20 cells/ml collected via venous blood draw
12 months follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Linkage to HIV care
Time Frame: 6 and 12 months follow up
Enrollment in an HIV clinic with a 2nd clinic visit
6 and 12 months follow up
Time to HIV care
Time Frame: 6 and 12 months follow up
Time from HIV testing to enrollment in an HIV clinic
6 and 12 months follow up
Time to receipt of ART
Time Frame: 6 and 12 months follow up
Time from HIV testing to receipt of ART
6 and 12 months follow up
Short-term retention in care: Missed visits
Time Frame: 6 and 12 months follow up
Missed visit count: number of missed visits accrued (count measure) based on scheduled visits determined by Ministry of Health clinical guidelines
6 and 12 months follow up
Short-term retention in care: Proportion of kept visits/scheduled visits
Time Frame: 6 and 12 months follow up
Proportion of kept visits/scheduled visits (kept + missed visits)
6 and 12 months follow up
Short-term retention in care: 4 month visit constancy
Time Frame: 6 and 12 months follow up
4-month constancy 4 month visit constancy: number of 4-month intervals with at least 1 kept visit
6 and 12 months follow up
Initiating ART
Time Frame: 6 and 12 months follow up
Percentage of eligible participants initiating ART
6 and 12 months follow up
Short-term retention on treatment
Time Frame: 6 and 12 months follow up
on ART at 6 and 12 month follow up: reporting taking ART at each follow-up
6 and 12 months follow up
HIV Viral load Suppression
Time Frame: 12 months follow up
defined as HIV RNA <1000 cells/ml collected via venous blood draw
12 months follow up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Receipt of co-trimoxazole
Time Frame: 6 and 12 months follow up
The percentage of participants who received co-trimoxazole
6 and 12 months follow up
Time to receipt of co-trimozazole
Time Frame: 6 and 12 months follow up
Time to receipt of co-trimoxazole
6 and 12 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Susan M Kiene

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Makerere University
University of Connecticut
Harvard School of Public Health (HSPH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan M. Kiene, PhD, San Diego State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UG2015_01
  • R01MH106391 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be shared with researchers within study investigators' institutions and with other researchers upon reasonable request.

IPD Sharing Time Frame

Data will be available to other researchers 2 years after publication of the trial results.

IPD Sharing Access Criteria

Contact principal investigators Drs. Kiene or Wanyenze to request access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings