NCT02497456

Brief Summary

The purpose of this study is to evaluate the impact of follow-up counselling after HIV diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to pre-antiretroviral therapy (pre-ART) care in Uganda.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
338

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Mar 2015

Shorter than P25 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

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

July 6, 2015

Last Update Submit

March 22, 2016

Conditions

HIV

Keywords

HIVCounsellingCareantiretroviral therapylinkageUgandaAfrica

Outcome Measures

Primary Outcomes (2)

  • The proportion of HIV-infected participants that register with an anti-retroviral therapy (ART) care provider within 3 and 6 months of HIV diagnosis and referral.

    6 months

  • The time between HIV diagnosis and linkage to pre-ART care.

    6 months

Secondary Outcomes (3)

  • Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care

    6 months

  • The time between learning that a participant is eligible for ART and ART initiation

    6 months

  • The proportion of participants who report adherence to daily cotrimoxazole prophylaxis at 3 and 6 months after HIV diagnosis through HBHCT among those that link to pre-ART care.

    6 months

Other Outcomes (1)

  • The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT.

    6 months

Study Arms (2)

Follow-up counselling

EXPERIMENTAL

Participants in the experimental arm will receive home-based HIV counselling and testing and referral for HIV care if found to have HIV infection. Additionally, participants will receive home-based follow-up counselling at 1 and 2 months after HIV diagnosis.

Behavioral: Follow-up counselling

Standard of care

NO INTERVENTION

Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection.

Interventions

Follow-up counsellingBEHAVIORAL
Follow-up counselling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-infected adult (≥18 years)
  • Willing to provide informed consent
  • Willing to receive follow-up counselling at home

You may not qualify if:

  • Previous or current receipt of HIV care from an ART provider
  • On-going participation in other health-related research
  • Intending to change residence in the next 6 months
  • Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness
  • HIV-uninfected participants
  • HIV negative adult (≥18 years)
  • Willing to provide informed consent
  • Willing to receive follow-up counselling at home
  • Intending to change residence in the next 6 months
  • Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRC/UVRI Uganda Research Unit on Aids

Masaka, Uganda

Location

Related Publications (1)

  • Ruzagira E, Grosskurth H, Kamali A, Baisley K. Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda. J Int AIDS Soc. 2017 Oct;20(2):e25014. doi: 10.1002/jia2.25014.

    PMID: 29052344DERIVED

Study Officials

  • Eugene Ruzagira

    MRC/UVRI and LSHTM Uganda Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 14, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 23, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)