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Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076996
Recruitment Status : Completed
First Posted : March 10, 2017
Results First Posted : February 18, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
FHI 360

Tracking Information
First Submitted Date  ICMJE February 8, 2017
First Posted Date  ICMJE March 10, 2017
Results First Submitted Date  ICMJE June 20, 2018
Results First Posted Date  ICMJE February 18, 2019
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date January 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
Percentage of Active Members Who Have at Least One Post in Group Chat Session. [ Time Frame: 3 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03076996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • Acceptability Score [ Time Frame: 3 months ]
    Acceptability score: A set of ten items asking if participants agreed=1 or disagreed=0 with statements on acceptability. Score represents a sum of the 10 items with a range of 0 to 10, and a greater number indicating agreement with more acceptability items.
  • Adherence to ART as Measured by the AACTG Adherence Assessment [ Time Frame: 3 months ]
    Proportion of participants who report not having missed any ART doses in past 3 days.
  • Adherence to Follow-up Visit Within 1 Month of Scheduled Date [ Time Frame: 3 months ]
    Retention in HIV services will be measured using data abstracted from the medical record system on date of visits between enrollment and the endline of this study. To be considered retained in HIV services, an individual must, at 3 months after enrollment, have attended his/her most recently scheduled clinical follow-up visit within 1 month of the date when it was scheduled to take place.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
  • Acceptability Score [ Time Frame: 3 months ]
    Acceptability score: each element of the intervention will be listed and the participant will be asked to rate the degree to which he/she likes the element on a scale of 0-4. The level of acceptability will be a sum of the scores for each item.
  • Adherence to ART as Measured by the AACTG Adherence Assessment [ Time Frame: 3 months ]
    ART adherence to ART will be measured using the AACTG Adherence Assessment
  • Adherence to Follow-up Visit Within 1 Month of Scheduled Date [ Time Frame: 3 months ]
    Retention in HIV services will be measured using data abstracted from the medical record system on date of visits between enrollment and the endline of this study. To be considered retained in HIV services, an individual must, at 3 months after enrollment, have attended his/her most recently scheduled clinical follow-up visit within 1 month of the date when it was scheduled to take place.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria
Official Title  ICMJE Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria
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.
Detailed Description

Study aim is to 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.

A single group, pre/posttest design including structured questionnaires with adolescents living with HIV. Additionally, we will abstract clinical data from the medical record system. We will also conduct in-depth interviews with a subset of participants, as well as health care staff who are engaged in the intervention, at endline.

The objectives of this study are:

  1. To examine the feasibility of implementing a mobile/electronic health (m/eHealth) intervention designed to improve retention in HIV care services and ART adherence among ALHIV ages 15-19 years through an online support group (using Facebook).
  2. To assess acceptability of and engagement in the intervention by the target audience to inform improvements to the intervention.
  3. To gather preliminary data on the psycho-social and health-related outcomes that the intervention is designed to affect to inform an outcome evaluation study that will be conducted following the conclusion of the feasibility study.
  4. To collect information on recruitment, informed consent and data collection processes to inform the outcome evaluation study of the current intervention that will be conducted once findings from this feasibility study are incorporated into the intervention design.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Single group pre/post design
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • HIV/AIDS
  • Adolescent Behavior
  • Medication Adherence
  • Health Behavior
Intervention  ICMJE Behavioral: Online support group

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
Study Arms  ICMJE Experimental: Online support group
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.
Intervention: Behavioral: Online support group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2018)
41
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2017)
50
Actual Study Completion Date  ICMJE January 15, 2018
Actual Primary Completion Date January 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nigeria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03076996
Other Study ID Numbers  ICMJE 930307
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party FHI 360
Study Sponsor  ICMJE FHI 360
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa S Dulli, PhD FHI 360
PRS Account FHI 360
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP