NCT02545673

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
567

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 31, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 24, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

5.9 years

First QC Date

August 31, 2015

Last Update Submit

November 16, 2023

Conditions

HIV

Keywords

Intervention StudiesAccess to Health CareSocial StigmaSocial Support

Outcome Measures

Primary Outcomes (1)

  • Undetectable HIV Viral load

    defined as HIV RNA \<20 cells/ml collected via venous blood draw

    12 months follow up

Secondary Outcomes (9)

  • HIV Viral load Suppression

    12 months follow up

  • Linkage to HIV care

    6 and 12 months follow up

  • Initiating ART

    6 and 12 months follow up

  • Short-term retention on treatment

    6 and 12 months follow up

  • Time to HIV care

    6 and 12 months follow up

  • +4 more secondary outcomes

Other Outcomes (2)

  • Receipt of co-trimoxazole

    6 and 12 months follow up

  • Time to receipt of co-trimozazole

    6 and 12 months follow up

Study Arms (2)

Enhanced Linkage

EXPERIMENTAL

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

Standard-of-care plus

ACTIVE COMPARATOR

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

Interventions

Enhanced linkage to careBEHAVIORAL
Enhanced Linkage
Standard-of-care plusBEHAVIORAL
Standard-of-care plus

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 18-59 years of age or an emancipated minor

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butambala, Mpigi, Mityana, Gomba Districts

Gombe, Uganda

Location

Related Publications (1)

  • Kiene SM, Kalichman SC, Sileo KM, Menzies NA, Naigino R, Lin CD, Bateganya MH, Lule H, Wanyenze RK. Efficacy of an enhanced linkage to HIV care intervention at improving linkage to HIV care and achieving viral suppression following home-based HIV testing in rural Uganda: study protocol for the Ekkubo/PATH cluster randomized controlled trial. BMC Infect Dis. 2017 Jul 3;17(1):460. doi: 10.1186/s12879-017-2537-z.

    PMID: 28673251DERIVED

MeSH Terms

Conditions

Social Stigma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Susan M. Kiene, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 10, 2015

Study Start

November 24, 2015

Primary Completion

September 30, 2021

Study Completion

October 31, 2021

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available to other researchers 2 years after publication of the trial results.
Access Criteria
Contact principal investigators Drs. Kiene or Wanyenze to request access.

Locations

UG(1)