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Contribution of Praise Messages to HIV Treatment Retention and Adherence Among Female Sex Workers in Ethiopia

Contribution of Praise Messages to HIV Treatment Retention and Adherence Among Female Sex Workers in Ethiopia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03127397
Enrollment
810
Registered
2017-04-25
Start date
2017-04-20
Completion date
2018-07-30
Last updated
2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

antiretroviral therapy, HIV/AIDS, ART adherence

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.

Detailed description

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. Inadequate adherence to ART medication, missed clinics visits and loss-to-follow-up, and failure to refill prescriptions are major barriers to achieving viral suppression. Non-adherence is associated with a range of individual, social, community, and structural factors, including low health literacy, a lack of social support, low socioeconomic status, substance abuse, stigma and discrimination, and a lack of access to a reliable source of ART drugs. ART patients' perceptions about a lack of health provider respect and mutual trust are a possible further barrier to adherence. Provision of HIV therapy within the MULU/MARPs drop-in-centers has attempted to mitigate some of the structural and social barriers to ART initiation and retention in care by bringing FSW friendly treatment services closer to clients and providing intensive counseling services, social and economic support services, and referrals to additional health services. Improving client perceptions of health care provider attitudes may further improve retention in care and adherence to treatment among FSW in Ethiopia. This study will measure the effects of praise message phone calls delivered the day after, and two weeks after, completing a ART appointment (i.e. initiation and/or prescription refill) on subsequent ART refills/HIV clinic visits. This study will be conducted within PSI/Ethiopia's USAID-funded MULU/MARPs program, which provides HIV testing, treatment, and other services to female sex workers (FSW) through a network of drop-in-centers (DICs) across Ethiopia. Consenting FSWs who are living with HIV, who are ART naive, and who are referred for ART initiation to one of the 25 drop-in-centers (DICs) selected for Test and Start implementation will be enrolled in the study. Pre-study analysis indicates that each DIC enrolls between 3-4 FSWs living with HIV on ART each month (mean: 3.6). Over the course of our 9 month study, the investigators expect to enroll a total of 810 study participants.

Interventions

BEHAVIORALPraise message phone call

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

Sponsors

Population Services International
CollaboratorOTHER
United States Agency for International Development (USAID)
CollaboratorFED
Reed College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Retention in care at 1 month1 month
ART adherence at 1 month1 month
Retention in care at 3 months3 months
ART adherence at 3 months3 months
Retention in care at 6 months6 months
ART adherence at 6 months6 months
Viral suppression at 6 months6 months

Countries

Ethiopia

Contacts

Primary ContactNicholas Wilson, Ph.D.
nwilson@reed.edu503-517-7733

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026