NCT03127397

Brief Summary

This study evaluates the effects of praise message phone calls on antiretroviral therapy (ART) initiation, adherence, and prescription refills. The investigators will use randomization to assign newly (diagnosed) HIV positive, ART naive, female sex workers (FSWs) in Ethiopia to a praise message phone call study arm or to a standard of care control study arm.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
810

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

April 20, 2017

Last Update Submit

April 9, 2018

Conditions

HIV/AIDS

Keywords

antiretroviral therapyHIV/AIDSART adherence

Outcome Measures

Primary Outcomes (7)

  • Retention in care at 1 month

    1 month

  • ART adherence at 1 month

    1 month

  • Retention in care at 3 months

    3 months

  • ART adherence at 3 months

    3 months

  • Retention in care at 6 months

    6 months

  • ART adherence at 6 months

    6 months

  • Viral suppression at 6 months

    6 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Praise Message

EXPERIMENTAL

Receives up to two praise message phone calls after each completed ART appointment.

Behavioral: Praise message phone call

Interventions

Praise message phone callBEHAVIORAL

Praise message phone calls after each completed ART appointment, up to two calls per month.

Praise Message

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written consent,
  • ART naive,
  • Female sex worker,
  • Living with HIV,
  • And, seeking care at a participating clinic

You may not qualify if:

  • No consent,
  • Previous ART,
  • Has not exchanged sex for money in past 12 months,
  • HIV negative,
  • And/or, has not sought care at a participating clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addis Ababa

Addis Ababa, Ethiopia

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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 Diseases

Central Study Contacts

Nicholas Wilson, Ph.D.

CONTACT

503-517-7733nwilson@reed.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Economics

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 25, 2017

Study Start

April 20, 2017

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

April 10, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

ET(1)