Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions HIV/AIDS
Adolescent Behavior
Medication Adherence
Health Behavior
Intervention Behavioral: Online support group
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Online Support Group
Hide Arm/Group Description Intervention content was delivered online through “secret” Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants’ knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership.
Period Title: Overall Study
Started 41
Completed 35
Not Completed 6
Reason Not Completed
Withdrawal by Subject             2
Lost to Follow-up             3
Literacy precluded participation             1
Arm/Group Title Online Support Group
Hide Arm/Group Description Intervention content was delivered online through “secret” Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants’ knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants
17
(15 to 19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
22
  53.7%
Male
19
  46.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Nigeria Number Analyzed 41 participants
41
religion  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Catholic
1
   2.4%
All other Christian
40
  97.6%
Time on ART  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants
3.8
(0.5 to 10.9)
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Currently enrolled in school, junior or secondary
5
  12.2%
Currently enrolled in school, post-secondary
15
  36.6%
Not currently enrolled, completed some secondary
6
  14.6%
Not currently enrolled, complete secondary
15
  36.6%
Currently employed  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
11
  26.8%
1.Primary Outcome
Title Percentage of Active Members Who Have at Least One Post in Group Chat Session.
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who initiated the intervention
Arm/Group Title Online Support Group
Hide Arm/Group Description:
Intervention content was delivered online through “secret” Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants’ knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership.
Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
32
  84.2%
2.Secondary Outcome
Title Acceptability Score
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Endline participants who participated in the intervention
Arm/Group Title Online Support Group
Hide Arm/Group Description:
Intervention content was delivered online through “secret” Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants’ knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership.
Overall Number of Participants Analyzed 34
Mean (Full Range)
Unit of Measure: Scores on Scale
9.9
(9 to 10)
3.Secondary Outcome
Title Adherence to ART as Measured by the AACTG Adherence Assessment
Hide Description Proportion of participants who report not having missed any ART doses in past 3 days.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed end line questionnaire
Arm/Group Title Online Support Group
Hide Arm/Group Description:
Intervention content was delivered online through “secret” Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants’ knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership.
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
29
  82.9%
4.Secondary Outcome
Title Adherence to Follow-up Visit Within 1 Month of Scheduled Date
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled in study at baseline
Arm/Group Title Online Support Group
Hide Arm/Group Description:
Intervention content was delivered online through “secret” Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants’ knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership.
Overall Number of Participants Analyzed 41
Measure Type: Count of Participants
Unit of Measure: Participants
37
  90.2%
Time Frame 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Online Support Group
Hide Arm/Group Description Intervention content was delivered online through “secret” Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants’ knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership.
All-Cause Mortality
Online Support Group
Affected / at Risk (%)
Total   0/41 (0.00%) 
Hide Serious Adverse Events
Online Support Group
Affected / at Risk (%)
Total   0/41 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Online Support Group
Affected / at Risk (%)
Total   0/41 (0.00%) 

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.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lisa Dulli
Organization: FHI 360
Phone: 919-544-7040 ext 11396
EMail: ldulli@fhi360.org
Layout table for additonal information
Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT03076996    
Other Study ID Numbers: 930307
First Submitted: February 8, 2017
First Posted: March 10, 2017
Results First Submitted: June 20, 2018
Results First Posted: February 18, 2019
Last Update Posted: March 5, 2019