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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05634265
Other study ID # STUDY00002554
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 31, 2019
Est. completion date December 14, 2019

Study information

Verified date November 2022
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to investigate whether a virtual peer support group improves ART knowledge, adherence, and mental health in youth living with HIV in Kenya.


Description:

Adolescents and young adults (AYA) living with HIV show lower ART adherence, higher loss to follow-up and higher AIDS-related mortality than other age groups. Innovative approaches are needed that address AYA's unique needs and improve their adherence and retention in HIV care. There is evidence that peer support and mobile messaging with healthcare workers (HCW) are two strategies that may be effective in this group, but their evaluation has been limited and no interventions have combined them. Since 2014, youth-run virtual support groups have spontaneously started at HIV clinics, using the mobile social media application WhatsApp. These groups present valuable case studies from which the proposed project will develop a structured social media intervention that combines peer and HCW support to improve ART adherence and retention, guided by the preferences of AYA. The SPECIFIC AIMS are to (1) Characterize the existing WhatsApp groups through in-depth interviews with members and detailed content analysis of the group's communications during a 6-week observation period. This will define the elements and features desired by AYA in a social media intervention. (2) Guided by findings from Aim 1, behavioral theory, and the study team's ongoing research on mobile messaging to improve ART adherence, to develop and refine structured content for a reproducible WhatsApp intervention that incorporates peer and HCW interaction. (3) Pilot the structured intervention for 6 months in another clinic and evaluate its impact on intermediate outcomes ART knowledge, depression and stigma.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date December 14, 2019
Est. primary completion date December 14, 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years to 24 Years
Eligibility Inclusion Criteria: - Living with HIV - On ART - Aware of HIV status - Has access to WhatsApp - Literate

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Vijana-SMART
The Vijana-SMART intervention is a facilitated peer group, delivered through WhatsApp. Intervention messages were developed based on findings from formative interviews and social support theory, which posits that individuals experience social support through informational, instrumental, companionship and emotional forms. Groups will have approximately 25 members and will be facilitated by a study team member, by sending weekly scheduled messages, answering participant questions, and encouraging group discussion. Intervention messages were designed based on guidance from formative interviews; topics include ART adherence, medication side effects, nutritional practices, depression, social support, HIV status disclosure, stigma, positive prevention, substance use, and contraception.

Locations

Country Name City State
Kenya Kayole Nairobi

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary ART information, motivation, behavioral skills Self-reported score on abbreviated Lifewindows IMB instrument 6 months
Primary Social support Self-reported score on SS-B instrument 6 months
Primary Stigma Self-reported score on abbreviated ALHIV-SS instrument 6 months
Primary ART adherence Self-reported score on Wilson 3-item scale 6 months
Primary Depression symptoms Self-reported score on PHQ-9 scale 6 months
Primary Resilience Self-reported score on abbreviated Connor-Davidson scale 6 months
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