NCT05634265

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 31, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

November 21, 2022

Last Update Submit

November 21, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • ART information, motivation, behavioral skills

    Self-reported score on abbreviated Lifewindows IMB instrument

    6 months

  • Social support

    Self-reported score on SS-B instrument

    6 months

  • Stigma

    Self-reported score on abbreviated ALHIV-SS instrument

    6 months

  • ART adherence

    Self-reported score on Wilson 3-item scale

    6 months

  • Depression symptoms

    Self-reported score on PHQ-9 scale

    6 months

  • Resilience

    Self-reported score on abbreviated Connor-Davidson scale

    6 months

Study Arms (1)

Pilot

EXPERIMENTAL

Participants will be offered the Vijana-SMART WhatsApp group intervention

Behavioral: Vijana-SMART

Interventions

Vijana-SMARTBEHAVIORAL

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.

Pilot

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Living with HIV
  • On ART
  • Aware of HIV status
  • Has access to WhatsApp
  • Literate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayole

Nairobi, Kenya

Location

Related Publications (1)

  • Ronen K, Mugo C, Kaggiah A, Seeh D, Kumar M, Guthrie BL, Moreno MA, John-Stewart G, Inwani I. Facilitated WhatsApp Support Groups for Youth Living With HIV in Nairobi, Kenya: Single-Arm Pilot Intervention Study. JMIR Form Res. 2023 Nov 13;7:e49174. doi: 10.2196/49174.

MeSH Terms

Conditions

Medication AdherenceDepression

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorBehavioral Symptoms

Study Officials

  • Keshet Ronen, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single-group pilot
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Global Health

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 2, 2022

Study Start

January 31, 2019

Primary Completion

December 14, 2019

Study Completion

December 14, 2019

Last Updated

December 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

De-identified participant data will be posted to the Harvard Dataverse

Time Frame
Upon publication of results
Access Criteria
Data may not be used for profit

Locations