NCT03076996

Brief Summary

This study will examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 8, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 18, 2019

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

February 8, 2017

Results QC Date

June 20, 2018

Last Update Submit

February 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of Active Members Who Have at Least One Post in Group Chat Session.

    Participants level of engagement in support group activities informs on the feasibility of intervention, measured by percentage of active members who have at least one post in group chat session.

    3 months

Secondary Outcomes (3)

  • Acceptability Score

    3 months

  • Adherence to ART as Measured by the AACTG Adherence Assessment

    3 months

  • Adherence to Follow-up Visit Within 1 Month of Scheduled Date

    3 months

Study Arms (1)

Online support group

EXPERIMENTAL

Participants will be enrolled to receive six sessions from the Positive Connections curriculum through the m/eHealth intervention that will use Facebook to conduct online structured support groups.

Behavioral: Online support group

Interventions

Participants will be enrolled to form five groups of 8 to 10 participants, and then participants will participate in the 6 sessions of the structured educational and group counseling curriculum through the online platform. The m/eHealth intervention components include: * Informational messages that reflect the content of the structured group counseling curriculum, Positive Connections, and are posted to the group wall on a regular basis * Moderated, closed group chats where ALHIV can interact with their peers and with a trained health counselor on a biweekly basis * Access to a trained counselor via Facebook Messenger (during normal business hours) for the duration of the intervention who will be able to provide information or basic counseling on ART/HIV care related issues, with referral to health care services as needed

Online support group

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV positive and currently on ART for at least 6 months
  • Age 15 to 19 years
  • Can demonstrate basic literacy necessary to participate in online chats

You may not qualify if:

  • Not planning to remain in the study area (within Akwa Ibom State) for the duration of the study (approximately 6 months)
  • Currently enrolled in an in-person support group
  • Currently enrolled in another research study related to HIV service retention or ART adherence
  • Critically or severely ill requiring hospitalization or such that the individual is unable to provide informed consent at the time of study recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SIDHAS-supported facilities

Uyo, Always Ibom, Nigeria

Location

Related Publications (1)

  • Dulli L, Ridgeway K, Packer C, Plourde KF, Mumuni T, Idaboh T, Olumide A, Ojengbede O, McCarraher DR. An Online Support Group Intervention for Adolescents Living with HIV in Nigeria: A Pre-Post Test Study. JMIR Public Health Surveill. 2018 Nov 28;4(4):e12397. doi: 10.2196/12397.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeAdolescent BehaviorMedication AdherenceHealth Behavior

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 DiseasesBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Limitations and Caveats

The non-probability sample precludes generalizing results beyond the study sample. Social desirability bias may play a role in participants' responses to questions about the intervention.

Results Point of Contact

Title
Dr. Lisa Dulli
Organization
FHI 360

Study Officials

  • Lisa S Dulli, PhD

    FHI 360

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single group pre/post design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2017

First Posted

March 10, 2017

Study Start

June 1, 2017

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

March 5, 2019

Results First Posted

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations