Contribution of "Praise Messages" to HIV Treatment Retention and Adherence Among Female Sex Workers in Ethiopia
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|ClinicalTrials.gov Identifier: NCT03127397|
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: Praise message phone call||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||810 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contribution of "Praise Messages" to HIV Treatment Retention and Adherence Among Female Sex Workers in Ethiopia|
|Actual Study Start Date :||April 20, 2017|
|Estimated Primary Completion Date :||July 30, 2018|
|Estimated Study Completion Date :||July 30, 2018|
|No Intervention: Standard of Care|
Experimental: Praise Message
Receives up to two praise message phone calls after each completed ART appointment.
Behavioral: Praise message phone call
Praise message phone calls after each completed ART appointment, up to two calls per month.
- Retention in care at 1 month [ Time Frame: 1 month ]
- ART adherence at 1 month [ Time Frame: 1 month ]
- Retention in care at 3 months [ Time Frame: 3 months ]
- ART adherence at 3 months [ Time Frame: 3 months ]
- Retention in care at 6 months [ Time Frame: 6 months ]
- ART adherence at 6 months [ Time Frame: 6 months ]
- Viral suppression at 6 months [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127397
|Contact: Nicholas Wilson, Ph.D.||firstname.lastname@example.org|
|Addis Ababa, Ethiopia|
|Contact: Woldemariam Girma email@example.com|