Using Social Media to Improve ART Retention and Treatment (SMART) Outcomes Among Youth Living With HIV (YLHIV) in Nigeria - The Youth SMART Study
Phase: NA
Conditions: Human Immunodeficiency Virus
Sponsor: FHI 360

 
 
Protocol: The Youth SMART study of an online support group intervention among YLHIV in Nigeria 
PHSC #1151489; Version 4.0; March 29,2019 
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Using Social Media to improve ART 
Retention and Treatment outcomes among 
youth living with HIV in Nigeria - The Youth 
SMART study 
 
March 29, 2019 
 
Protocol Version 4.0 
PHSC Study #1151489 
 
Date:  
March 2019 
 
Funded by:  
 
USAID – YouthPower Action 
Study Sponsor:  
FHI 360 
FHI 360 Project Leader:  
Lisa Dulli, FHI 360 
Study Sites:  
Akwa Ibom and Cross Rivers States, Nigeria 
 
 
 
 
 
Principal Investigator 
Dr. Lisa Dulli, FHI 360 
Co-Investigators: 
Dr. Donna McCarraher, FHI 360 
Dr. Mario Chen, FHI 360 
Ms. Kate Plourde, FHI 360 
Ms. Kathleen Ridgeway, FHI 360 
Ms. Catherine Packer, FHI 360 
Dr. Tosin Idaboh, FHI 360 
Ms. Kate Murray, FHI 360 
SIDHAS Technical Advisors 
Dr. Hadiza Khamofu, FHI 360 
Dr. Oluwasanmi Adedokun, FHI 360 
Site Study Coordinator 
TBD 
Nigeria Investigators 
Professor Oladosu Akanbi Ojengbede, Center for Population and Reproductive Health (CPRH) 
Dr. Adesola O. Olumide, CPRH 
Ms. Tolulope Mumuni, CPRH 

 
 
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Contents 
Study Summary ....................................................................................................................................................... 5 
Acronyms and Abbreviations .................................................................................................................................. 6 
Background ............................................................................................................................................................. 7 
Nigeria ................................................................................................................................................................. 8 
Feasibility Study Results .................................................................................................................................... 10 
Study Aim and Objectives ..................................................................................................................................... 10 
Methods ................................................................................................................................................................ 11 
Design ................................................................................................................................................................ 11 
Intervention Description ................................................................................................................................... 11 
Standard of care services .............................................................................................................................. 13 
Study Setting ..................................................................................................................................................... 13 
Study Population ............................................................................................................................................... 14 
Sample Size and Sampling Design ..................................................................................................................... 14 
Sample size .................................................................................................................................................... 14 
Sampling procedure and recruitment ........................................................................................................... 14 
Randomization procedures ........................................................................................................................... 15 
In-depth Interviews ....................................................................................................................................... 16 
Data collection .................................................................................................................................................. 16 
Structured questionnaires............................................................................................................................. 17 
Clinical data ................................................................................................................................................... 17 
Participation data .......................................................................................................................................... 17 
In-depth interviews ....................................................................................................................................... 17 
Cost data ....................................................................................................................................................... 18 
Measures ........................................................................................................................................................... 18 
Objective 1 .................................................................................................................................................... 18 
Objectives 2 and 3 ......................................................................................................................................... 18 
Objective 4: ................................................................................................................................................... 19 
Objective 5: ................................................................................................................................................... 19 
Objective 6: ................................................................................................................................................... 20 
Data Management and Analysis ........................................................................................................................... 21 
Data management ............................................................................................................................................. 21 
Structured questionnaires............................................................................................................................. 21 
Clinical data ................................................................................................................................................... 22 
Participation data .......................................................................................................................................... 22 
In-depth interviews ....................................................................................................................................... 22 

 
 
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Cost data ....................................................................................................................................................... 22 
Analyses............................................................................................................................................................. 22 
Primary Objective .......................................................................................................................................... 22 
Analysis plan for other objectives ................................................................................................................. 23 
In-depth interviews ....................................................................................................................................... 23 
Study Management and Study Team Roles .......................................................................................................... 23 
Ethical Issues ......................................................................................................................................................... 24 
Considerations for inclusion of minors ............................................................................................................. 24 
Informed consent .............................................................................................................................................. 24 
Risks to Participation ......................................................................................................................................... 25 
Anticipated benefits to participation ................................................................................................................ 26 
Compensation ................................................................................................................................................... 26 
Participant privacy and confidentiality ............................................................................................................. 26 
Anticipated Outputs and Results Dissemination................................................................................................... 26 
Timeline: ................................................................................................................................................................ 27 
Appendix 1: SIDHAS-support ART standard services for YLHIV ............................................................................ 28 
Appendix 2: Facebook data policy ........................................................................................................................ 29 
Appendix 3: Safety at Facebook ............................................................................................................................ 29 
Appendix 4: What are the privacy settings for groups? ........................................................................................ 29 
Appendix 5: How do I remove or block someone from a group? ......................................................................... 29 
References ............................................................................................................................................................. 30 
 

 
 
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Study Summary 
 
Title:  
Using Social Media to improve ART Retention and Treatment outcomes among youth 
living with HIV in Nigeria - The Youth SMART study. 
IRBNet #:  
1151489 
Purpose:  
Study aim is to examine the effect of an online structured support group intervention 
(SMART Connections) designed to improve retention in HIV care services among youth 
ages 15-24 years living with HIV enrolled in ART services. 
Design:  
A randomized controlled trial in which youth living with HIV (YLHIV) will be allocated to 
standard of care (control) or standard of care plus an online support group and 
followed for 12 months. Structured questionnaires will be administered to participants 
at baseline, 6 and 12 months. Clinical data will also be extracted on participants. In-
depth interviews with a subset of participants and intervention implementers will be 
completed at the end of the intervention period. 
Study Population:  
YLHIV, ages 15 to 24 years, who are currently taking ART for up to 12 months, including 
newly initiating patients. 
Study Site(s): 
SIDHAS-supported ART clinics located in Cross River and Akwa Ibom States in Nigeria. 
Study Duration:  
Study duration is approximately 18 months from enrollment to endline data collection. 
Objectives: 
 
1. To test the effectiveness of a structured online support group (SMART Connections) to increase 
retention in HIV services among YLHIV. 
2. To examine the effect of SMART Connections on secondary outcomes of social support, HIV knowledge 
and treatment literacy, and ART adherence among YLHIV. 
3. To test the potential mediating effect of social support on the relationship between the intervention 
and primary outcome. 
4. To document the costs of the intervention and calculate the unit cost per YLHIV retained. Intervention 
costs will also be descriptively compared to the costs of adolescent-focused, in-person support groups 
in the region. 
5. To document participant engagement and perspectives regarding the content and delivery of the 
intervention to inform scalability and sustainability. 
6. To document implementation and health care provider and support group facilitator perspectives 
regarding intervention content and delivery to inform scalability and sustainability. 
 
Primary Endpoints/Outcomes:  
The primary outcome of this study is retention in ART services. Secondary outcomes include social support, 
ART adherence, and HIV knowledge and treatment literacy. 
 
 
 
 

 
 
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Acronyms and Abbreviations 
AACTG 
Adult AIDS Clinical Trials Group 
YLHIV 
Youth living with HIV 
ART 
Anti-retroviral Treatment 
AUDIT/AUDIT-C 
Alcohol Use Disorders Identification Test 
CBO 
Community-based organization 
EC 
Ethics Committee 
FHI 360 
Family Health International 
GoN 
Government of Nigeria 
IRB 
Institutional review board 
IDI 
In-depth interview 
IT 
Information Technology 
LGA 
Local Government Area 
LMIC 
Low and middle income countries 
LTF 
Loss to follow-up 
m/eHealth 
Mobile/electronic health 
MOS-SSS 
Medical Outcomes Study – Social Support Survey 
ODK 
Open Data Kit 
OIRE 
FHI 360’s Office of International Research and Ethics 
PHQ-8 
Patient Health Questionnaire Depression Scale - 8 
PHSC 
FHI 360’s Protection of Human Subjects Committee 
PI 
Principal Investigator 
PLHIV 
People living with HIV 
RMNCH 
Reproductive, Mother, Newborn and Child Health 
SHERO 
Supporting Health and Redemption Organization  
SIDHAS 
Strengthening Integrated Delivery of HIV/AIDS Services 
SMS 
Short messaging service 
USAID 
United States Agency for International Development 
YP Action 
YouthPower Action project 
 
 
 

 
 
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Background 
Globally, young people 15 to 25 years old account for more than 30% of all new HIV infections, the majority 
of whom live in sub-Saharan Africa.1 The epidemic among youth living with HIV (YLHIV) differs substantially 
from that among adults, as mortality among YLHIV is increasing rather than decreasing over time. Between 
2005 to 2012, the numbers of HIV-related deaths among YLHIV increased by 50%, while the number of 
deaths among all ages decreased by 30%.2-4  
Youth face many challenges with adherence to antiretroviral therapy (ART) and retention in HIV care, 
including fear of stigma or disclosure to others, lack of social support, and limited knowledge about the 
disease itself.5-8 There is a lack of age-disaggregated data on ART coverage for youth, largely due to reporting 
of program data for ages less than 15 and 15 years and older; however, available data show that even when 
youth are enrolled in care, they experience higher loss to follow up (LTF) and suboptimal adherence 
compared to younger children or adults.7,9 
YouthPower Action (YPA) conducted a review of the peer-reviewed and grey literatures to identify 
interventions implemented in low and middle -income countries (LMIC) that have been shown to improve 
retention and adherence among youth (ages 10-19), as well as interventions that were successful among 
youth and adults (≥ 20 years of age) and had potential to be adapted for youth. Most interventions were 
conducted among adults and aimed to improve ART adherence, while fewer interventions targeted long-
term retention in care. We identified that group counseling interventions show some evidence for 
effectiveness both on adherence and retention in care among adults, and have been implemented to a 
lesser degree with youth in LMIC.10-14 
Our review also showed that mobile phones are an acceptable platform for delivering interventions to adult 
PLHIV in LMIC settings. mHealth interventions such as mobile reminders and interactive voice or SMS 
response also have some evidence of effectiveness in improving adherence in people living with HIV (PLHIV) 
in LMIC settings.15-20 Although there is no published evidence for these interventions’ effectiveness on YLHIV 
in LMIC, there is preliminary evidence for the feasibility and potential impact on ART adherence on youth in 
high income countries.21-24 Furthermore, two recent studies (in South Africa and the US) have integrated 
social networking into interventions for youth and youth living with HIV in order to improve social support 
and found them to be acceptable and feasible.25,26 Increasing availability of internet, feature and smart 
phones in LMIC makes these interventions possible. Therefore, mHealth interventions present an innovative 
opportunity to apply successful adherence and retention strategies from adults in LMIC and youth in high-
income countries to youth in LMIC.  
There is a small body of evidence supporting the effectiveness of support groups to improve health 
outcomes among PLHIV. In a quasi-experimental study in Kenya conducted among adult PLHIV, researchers 
found statistically significant decrease in LTF among intervention participants who participated in support 
groups compared to the comparison group.11 Munoz and colleagues conducted a quasi-experimental study 
of a multi-faceted intervention that included support groups and found that, at 2 years, a significantly higher 
proportion of intervention group participants had >95% ART adherence compared to the comparison group 
(79.3% versus 44.1%), and a greater odds of viral load suppression (OR=2.46, 95%CI(1.03, 6.09)).27 In a 
second study conducted in Kenya, Achieng and colleagues found that adherence was statistically 
significantly higher among those who participated in > 3 support group meetings (90% vs. 83%, p < 0.05), 
and who had pill counts performed by their clinician (90% vs. 76%, p = 0.001).28 The role of social support 
has been extensively studied for a number of health outcomes and is correlated with many beneficial health 
effects. For PLHIV, social support can be limited because of the stigmatized nature of the disease. Support 
groups hold potential for increasing retention and adherence. One systematic review conducted in 2015 
found that support groups were associated with an overall increase in retention in care.29  
Support groups provide PLHIV an opportunity to extend their social network and to increase the social 
support available to them from others who are experiencing many of the same health and social issues that 

 
 
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they are experiencing. Peer influences play a substantial role during the youth period. Older youth (age 15-
21), in particular, have increased autonomy and independence compared to younger youth, and frequently 
look towards peers during this time for experiences and relationships that often shape and define their early 
young adult perspectives and identities. However, despite the potential benefits of support groups, in-
person support groups also present specific challenges to long-term sustainability such as costs associated 
with travel to meeting groups which are often beyond the means of participants and must be supported by 
the group organizers. Support groups can also encounter difficulties organizing meetings at times and places 
convenient to all members. Additionally, not all people are interested in or comfortable in in-person group 
settings. 
Nigeria 
Nigeria is experiencing a generalized HIV epidemic. Although the overall prevalence of HIV in Nigeria is small 
compared to many countries in Eastern and Southern Africa, because of the size of its population, the 
country has the second largest burden of the disease in the world with an estimated 3,438,442 people 
currently living with HIV.30 
Consistent with other countries in the region, youth (15-21) living with HIV in Nigeria experience high LTF 
from HIV treatment services, with the greatest losses occurring early in treatment. The USAID-funded 
Strengthening Integrated Delivery of HIV/AIDS Services (SIDHAS) project supports health facilities in PEPFAR 
designated priority, local government areas (LGA) throughout Nigeria. An analysis of data from SIDHAS in 
Rivers, Cross River, Lagos and Akwa Ibom States found that LTF is greatest in the first year after ART 
initiation and drops off considerably after 1 year (Figure 1)1. Among 6648 YLHIV ages 15-21 years who 
enrolled in ART between 2009 and 2016, 2939 were listed as LTF as of March 2017. Figure 1 below 
demonstrates the timing to LTF, with nearly half, 1430 or 49%, of those LTF never returning after their initial 
ART visit. A full two-thirds of those LTF fall out in the first three months after initiation. 
 
1 Figure 1 represents the number of months of ART received by a patient. At the initial visit, the patient is given 1 month (30 days) of 
ART, so the first column represents those who were initiated on ART, given 1 month of medication and never returned. Patients are 
typically given monthly refills for at least the first year, so the number of months of ART corresponds to the number of ART clinic 
visits. 
 

 
 
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2 
Table 1. Current status (as of March 2017) of a 12-month cohort of ART patients ages 15-21 
who enrolled in ART between April 2015 and March 2016 in Akwa Ibom and Cross River 
states (n=2,043). 
Status 
n 
% 
Active on treatment 
602 
29.5% 
Active, transferred in to ART 
9 
0.4% 
Transferred out of service 
63 
3.1% 
Dead 
22 
1.1% 
Stopped ART 
15 
0.7% 
Lost to follow  
1332 
65.2% 
 
Anecdotal evidence collected during an information gathering trip in October 2016 for this study revealed 
that in-school youth, in particular, have a difficult time traveling to health facilities. Many SIDHAS staff and 
health facility personnel stated that many students in Nigeria attend boarding schools, and they often find it 
difficult to leave school to attend health care appointments. Students may not disclose their HIV status to 
teachers or other students, so leaving school for anything to do with their HIV infection can be challenging. 
Even among those YLHIV who live at home, going to health facilities and to meetings can raise questions for 
those to whom the YLHIV have not disclosed their HIV status. Therefore, SIDHAS is keen to work with YP 
ACTION to develop and test alternatives to existing strategies to identify additional tools to support better 
health outcomes among YLHIV.  
Given the increasing access to and use of mobile phone technology in Nigeria, mHealth strategies have 
potential to meet the informational and social support needs of YLHIV who might not be able to participate 
or interested in in-person support groups. According to a survey conducted in 2014 by the Pew Research 
Center, 89 percent of Nigerians ages 18 and older own a cell phone, and phone ownership has been 
increasing at a dramatic rate over the past decade.31 A 2012 study conducted in Nigeria found that, at the 
time, more than half of females ages 12-30 years owned a phone and almost all of the girls and women who 
 
 
 
1430
389
162 133 101
70
74
46
43
34
34
269
85
61
8
0
200
400
600
800
1000
1200
1400
1600
1
2
3
4
5
6
7
8
9
10
11 12 to
23
24 to
35
36 to
59
60+
Figure 1. Number of months on ART among YLHIV ages 15-21 initiating 
ART who were LTF in Lagos, Rivers, Akwa Ibom and Cross River States, 
Nigeria, 2009-2016 (n=2939 (44%) LTF of 6648 ever enrolled).
Number of months on ART (including refills)
Number of ART 
patients
67%

 
 
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did not own a phone had access to one supporting the feasibility of using mobile phones as a medium for 
health interventions.32  
Feasibility Study Results 
From June 2017 to January 2018, YP Action conducted a feasibility study of an online support group 
intervention designed to improve ART adherence and health service retention among YLHIV (FHI 360 PHSC 
study number 930307). The feasibility study included a pilot test of 5 structured sessions delivered by 
trained facilitators through Facebook groups to groups of 8 YLHIV.  A total of 41 participants completed a 
baseline questionnaire; 38 of 41 enrolled and participated in the online groups. For those who did not 
participate, one was excluded because her literacy was determined to be too low to effectively participate 
after recruitment, one person fell ill and was unable to participate in the initial group meeting so was 
excluded, and a third person dropped out because she said there was no cellular network coverage near her 
home. Thirty-five of 38 participants completed the endline interview.  
All 35 respondents reported at endline that they: enjoyed being a member of the online group; received 
useful information from the group; better understood their HIV infection after participating in the group; 
and felt comfortable interacting with both the other members and the facilitators. All 35 respondents also 
agreed that they would like to continue to be part of the group, that Facebook groups are a good way for 
young people with HIV to interact and that such groups are a good way to get information to people living 
with HIV.  
Among the 35 participants who completed the endline interview, 34 reported participating in at least one 
online session, with the 35th person reporting connectivity issues. About half (n=16) participated in all five 
sessions and 26 participated in three or more sessions. In terms of posting frequency, which was daily, five 
people stated they felt the facilitator postings were too frequent, and 27 reported the frequency was about 
right. Thirty-one out of 35 reported that they made new friends through the group. 
We also identified a number of challenges during the feasibility study. In terms of enrollment, we learned 
that the original data on which we estimated numbers of eligible participants did not have updated ages. 
This led to a situation where, when our data collectors went to the selected study sites, there were far fewer 
eligible patients than anticipated, which caused delays in recruitment. As a result, we have changed the way 
the data from the SIDHAS project are extracted to provide a more accurate reflection of currently eligible 
patients; we have also expanded the age range to include up to 24 years olds. A second, important finding, 
was that many YLHIV under 18 who were still in their parent’s/guardian’s care did not know, according to 
the parent/guardian, that the disease for which they were being treated was HIV. This caused the 
parent/guardian to refuse participation on behalf of the YLHIV to prevent disclosure. For this outcome study, 
this is less likely to be an issue. The feasibility study included ART patients who had been on ART for a 
minimum of 6 months, and included many who were perinatally infected. This current study will recruit 
newly initiating ART patients who will be more likely to know their HIV status because most will have just 
been diagnosed. 
Study Aim and Objectives 
The principle aim of this research is to gather evidence on an intervention designed to improve retention in 
HIV care services among youth living with HIV, ages 15-24 years, enrolled in ART services.  
Specific objectives include: 
1. To test the effectiveness of a structured online support group (SMART Connections) to increase 
retention in HIV services among YLHIV. 
2. To examine the effect of the SMART Connections on secondary outcomes of social support, HIV 
knowledge and treatment literacy, and ART adherence among YLHIV. 

 
 
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3. To test the potential mediating effect of social support on the relationship between the intervention 
and primary outcome. 
4. To document the costs of the intervention and calculate the unit cost per YLHIV retained. Intervention 
costs will also be descriptively compared to the costs of adolescent-focused, in-person support groups 
in the region. 
5. To document participant engagement and perspectives regarding the content and delivery of the 
intervention to inform scalability and sustainability. 
6. To document implementation and health care provider and support group facilitator perspectives 
regarding intervention content and delivery to inform scalability and sustainability. 
Methods 
Design 
This study will be a randomized controlled trial (RCT) of the SMART Connections, a socio-behavioral 
intervention using an online social media either platform (Facebook) designed to improve retention in HIV 
care services. Participants will be randomized to the online intervention group or control group.  
The hypothesis being tested with this study is: 
YLHIV who participate in SMART Connections will be more likely to be retained in HIV care at 12 
months after enrollment than YLHIV in the control group. 
Secondarily, we will also test the role of social support as a potential mediator of the intervention effects on 
retention in care: 
 
Among YLHIV enrolled in ART services, those in the treatment group who are exposed to SMART 
Connections will have greater social support and, in turn, will be more likely to be retained in HIV 
care services at 12 months compared to those in the control group. 
Structured questionnaires will be completed through face-to-face interviews with YLHIV participants at 
baseline, at six months, and at endline, which will occur after 12 months of participation. Clinical data on 
ART diagnosis, visits and biological tests (CD4 and viral load) will be abstracted from electronic patient 
medical records. At six months and endline, we will repeat the structured questionnaires from baseline, 
adding questions on participation and perspectives on the intervention. Additionally, in-depth interviews 
(IDI) with a subset of participants will be conducted at the completion of the intervention.  
We will use a software program, Grytics, which is specifically designed to collect and analyze Facebook 
group data. We will collect data on the number of active members, the number of posts, the number of 
comments, and the number of reactions to posts by type (“wow,” “love,” “like,” “angry,” “haha,” and “sad”), 
per session. We will also document the number and reason for personal messages to the group facilitator, 
such as question about side effects, question about appointment, etc. Monitoring the push messages from 
the group facilitator will also permit analysis of the degree of fidelity to the messages and delivery schedule 
that is implemented. 
Intervention Description 
The intervention to be tested is based on our current understanding of existing evidence gathered through a 
systematic literature review identifying intervention strategies that have been shown to increase ART 
adherence or retention in HIV care among adults or youth in LMIC settings. The systematic review was 
supplemented with a review of effective interventions among youth in high-income countries that had the 
potential to be adapted to a LMIC setting. From these reviews, two intervention strategies stood out: 
structured group counseling and using mobile technologies to improve reach and uptake of health 
information and services. Experiences from the SIDHAS staff in Nigeria indicate that face-to-face group 
counseling or support groups have proven a challenge to implement in this setting. Difficulties finding times 

 
 
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when youth are available to meet, coupled with the expenses associated with travel and meeting venues, 
limit the sustainability of this approach at this time. Therefore, the focus of this experimental intervention 
will be to deliver components of the structured group counseling through a mobile/electronic technology 
platform (m/eHealth). A limitation of this intervention is that, although it addresses psycho-social barriers to 
adherence and retention, it does not directly address other types of barriers such as difficulties accessing 
HIV care facilities. The current intervention has been revised based on findings from the feasibility study.  
The overall aim of the intervention is to promote retention in HIV care services through leveraging social 
networks and psycho-social support, with an emphasis on informational, emotional and network dimensions 
of social support. The platform selected for this intervention is Facebook. To inform this decision, workshops 
were conducted with YLHIV in Akwa Ibom State prior to the feasibility study to gather input into 
intervention design. Text messaging through SMS platform and Facebook were the top two platforms 
suggested by participants. Facebook has been used in a similar manner for other health promotion 
interventions.25,33-39 More information on Facebook groups and Facebook’s data use policy are attached to 
this protocol in Appendices 2 through 5. 
The 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 several times a week, for 
approximately 4 to 4.5 months  
• 
Moderated, closed group chats in a “secret” Facebook group where YLHIV can interact with their 
peers and with a trained health counselor  
• 
Access to a trained counselor via Facebook Messenger 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  
FHI 360 will work with the SIDHAS local implementing partners that are responsible for community-based 
interventions to carry out SMART Connections. These partners include the Women Community Livelihood 
Foundation (WOCLIF) based in Uyo and the Positive Development Foundation (PDF) in Calabar Municipal 
and Calabar South LGAs. We will recruit support group 
facilitators from these organizations to train to deliver 
the online support group intervention. These 
facilitators have been extensively trained to facilitate 
in-person support groups for other HIV-related 
support groups. They will receive intervention training 
and an implementation guide that outlines the key 
informational messages that will be shared, group 
discussion prompts, and a delivery schedule. The 
informational messages have been developed from 
key messages identified in each of the Positive 
Connections curriculum sessions. Positive Connections 
is a 14-session curriculum, developed by members of 
the Interagency Youth Working Group with funding 
through the USAID Prevention Technologies 
Agreement.40 Positive Connections curriculum 
provides guidance to professionals trained in HIV 
counseling to create support groups for YLHIV.  
Each SMART Connections group will consist of approximately 15 to 20 YLHIV, and approximately 15 groups 
in total will be formed. Once a sufficient number of YLHIV have been recruited and randomized to form a 
group, the group will begin with an initial, in-person group meeting with the group facilitator. Online groups 
will be formed by local government area to ensure participants are able to travel to this initial meeting. 
Figure 2: Positive Connections topics: 
• Understanding HIV 
• Disclosure and Developing Trust in Relationships 
• Treatment and Adherence 
• Nutrition and Health 
• Growing and Changing 
• Sex and Relationships 
• Pregnancy: Planning and Prevention 
• Sexual Health and Positive Prevention 
• Violence and HIV 
• Communication and Problem-Solving Skills 
• Exploring Your Feelings 
• Knowing Your Rights: Handling Stigma and 
Discrimination 
• Making Decisions and Planning for the Future 
• Your Support Network and Next Steps. 

 
 
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During this meeting, the participants will have an opportunity to meet one another, possibly for the first 
time, and the facilitators face-to-face. The intent and design of the intervention will be described and 
ground rules for participation will be set. Ground rules will be discussed and accepted by the group 
members, but at a minimum, group members will be advised not to talk about what is discussed in the 
online group with people outside of the group. A brief activity that highlights confidentiality and the 
consequences of breaking confidentiality will be implemented. During this meeting, the participants will also 
receive their study phones and the facilitator will record their contact information (telephone numbers, 
email addresses and Facebook ID). Those who prefer can use their existing sim card (in the study phone), 
phone or Facebook ID to participate in the project, as long as they are willing to provide the information to 
the facilitator to enable them to be enrolled in the group. The facilitator will enroll each participant into the 
virtual group, and then a demonstration of how to open, log-in, post comments and log-out of the group will 
be made. Each participant should demonstrate the ability to log in and out to the facilitator. The facilitator 
will also set conditions and expectations for responding to posts and messages by the facilitator, such as 
limiting his/her responses to group members to business hours and perhaps certain times of the day. Also, 
the facilitator will instruct the participants if they need to contact the facilitator individually, to send a 
message to call back when it is safe to do so without risk of breaking confidentiality and the facilitator will 
call the person. 
For those participants who are randomized to the control arm, they will receive their study phone when 
they return for their next clinic visit. 
Standard of care services 
All study participants, in both study arms, will receive standard services currently available to YLHIV in these 
SIDHAS-supported facilities and communities. The services currently include: routine clinical care for HIV 
treatment including laboratory testing (CD4, viral load tests); active case management by community 
volunteers with intensive adherence support during the first 4 weeks of ART; adherence support through 
phone calls and SMS reminders; and enhanced adherence counseling for patients with unsuppressed viral 
loads. 
Additionally, ALHIV 15 to 19 years have the option of attending in-person support groups based on the 
Positive Connections curriculum in five of the eight study LGAs. ALHIV support groups are capped at 20 
participants each. Groups meet once a month and pay transportation reimbursements and provide 
refreshments to those who attend. These groups are open to all and participants join and leave at any point, 
without regard to the Positive Connections curriculum. Groups are also provided educational materials for 
participant use. Youth 20 and 21 years old can attend similar, monthly, in-person support groups for adults 
living with HIV, following a Positive Health, Dignity, and Prevention curriculum used by the Ministry of 
Health, but no transportation payments are made. 
The current SIDHAS project ends in September 2018, with field activities closing out in June 2018; therefore, 
it is currently unknown which support services will continue beyond these dates. A follow-on project is 
planned and details will be recorded once USAID Nigeria releases this information. In any case, we will 
include questions to assess exposure to other support groups and other community-based support 
activities. 
Study Setting 
This study will take place in six local government areas (LGA) in Akwa Ibom and two LGAs in Cross River 
states. Akwa Ibom and Cross River lie adjacent to one another and share many socio-cultural similarities. 
The two states also represent the highest HIV prevalence in Nigeria. All of the study facilities lie within 
approximately two hours travel by car from the FHI 360 Akwa Ibom state office in Uyo, including the two 
LGAs in Cross River. The SIDHAS program currently supports a total of 85 health facilities in these eight LGAs 
service approximately 1,500 YLHIV ages 15-24 who are currently on ART. 

 
 
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Study Population 
The primary population of interest for this study is YLHIV, ages 15-24 years in Akwa Ibom and Cross River, 
Nigeria. Eligibility criteria to participate in the study include: 
• 
HIV positive and know their status 
• 
Actively on ART for up to 12 months including newly initiating patients 
• 
Age 15 to 24 years 
• 
Can demonstrate basic literacy necessary to participate in online chats3 
Exclusion criteria include: 
• 
Unable to attend the initial intervention group meeting for treatment participants 
• 
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 
Sample Size and Sampling Design 
Sample size 
Our primary outcome is retention in HIV care. We will need to recruit 250 experimental participants and 250 
control participants to be able to detect a 0.125 difference in the cumulative probability of retention at 12-
months (0.45 in the control group and 0.575 in the intervention group), corresponding to a hazard ratio of 
0.69, with 80% power and 5% significance level for a two-sided comparison using the log-rank test. These 
calculations also assumed exponential times to event and a 10% loss to follow-up. 
Sampling procedure and recruitment: Eligible participants will be sequentially recruited from patients who 
attend clinic visits at the study facility until the total sample size has been achieved. Patients currently 
attend ART clinic visits monthly. If recruitment extends beyond 8 weeks, alternately, we will ask the health 
ART clinic point person to identify potentially eligible patients based on eligibility criteria from their facility 
records and to contact the person by telephone to tell them about the study and, if interested, to invite 
them to come to the facility if they may be interested in participating in a research study. 
The health care providers who provide ART services to patients within the study facilities will be oriented on 
the study and asked to refer YLHIV ages 15-24 as they present to services to the study staff member who will 
be stationed in the facility during the recruitment period. ART services are set within the general outpatient 
clinic where the reason for the patient’s visit cannot be known by others waiting with them. Study staff will 
be stationed in a separate location within the facility so that they do not know with whom the health staff 
have discussed the study. YLHIV who approach the study staff will be informed about the research study.  
Potential participants will be assessed for eligibility and written informed consent will be obtained from 
each participant prior to enrollment in the study. The study staff will communicate verbally that the study is 
for youth living with HIV and the groups will be made up of youth living with HIV. The study staff will verbally 
confirm that the potential participant believes he/she meets the study eligibility criteria. Parental consent 
will also be obtained for non-emancipated potential participants who are ages 15-17 years. 
 
3 The design of the intervention will require basic (e.g. at least some primary school) literacy to read and respond to 
text messages and online chats. We want to ensure those who are enrolled in the study have the potential to benefit 
from the intervention. Therefore, during recruitment, the data collector will screen potential participants by providing 
3 short messages that will be part of the intervention and ask the participant to read them aloud. Only those who can 
read the messages will be eligible to enroll in the study. Data collectors will record the number of potential participants 
who are deemed ineligible and the reason for ineligibility, including inability to read the screening messages. During the 
feasibility phase, only one person was deemed initially eligible, but then determined to be unable to read adequately 
to participate. 

 
 
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The total number of participants will be recruited sequentially and will likely be proportionate to the total 
eligible patient volume across participating facilities as illustrated in (Table 2). These numbers are just 
illustrative and not set recruitment targets. 
 
Table 1. Participating health facilities, estimated number of eligible patients and sampling plan for facilities. 
State 
LGA 
Facility 
Est. # of 
eligible 
patients 
per facility 
Total 
per 
LGA 
% of 
sampl
e 
Distribution of sample 
by study arm 
Control 
Arm 
(n=250) 
Treatment 
arm 
(n=250) 
Akwa 
Ibom 
Ikot Ekpene 
Ikot Ekpene Primary Health Centre 
70 
130 
17.69
% 
44 
44 
Ikot Ekpene General Hospital 
60 
Mbo  
Enwang Primary Health Centre 
20 
87 
10.88
% 
27 
27 
Okobo   
Okobo General Hospital 
12 
52 
7.07% 
18 
18 
Okopedi Primary Health Centre 
40 
Oron  
Oron General Hospital (Iquita) 
65 
146 
19.86
% 
50 
50 
Oron Operational Base PHC 
81 
Uruan  
Idu-Uruan Primary Health Centre 
34 
111 
15.10
% 
38 
38 
Ituk Mbang Methodist General Hospital 
77 
Uyo 
Uyo Base Primary Health Centre 
88 
1177 
15.92
% 
40 
40 
University of Uyo Teaching Hospital 
29 
Cross 
River 
Calabar Municipal Calabar General Hospital 
39 
39 
60 
13.47
% 
34 
34 
 
Calabar South  
Dr Lawrence Henshaw Memorial 
Hospital 
20 
Ekpo Abasi Primary Health Center 
40 
Totals 
735 
100% 
250 
250 
 
Randomization procedures 
A randomization manager from FHI 360, who is not otherwise involved in the study, will prepare a 
computerized randomization list using permuted blocks before the start of the study. These envelopes will 
be given to study staff in charge of the enrollment process. These staff will open the randomization 
envelopes and inform the participant which group s/he has been assigned to. Participants will be 
randomized in a 1:1 ratio to proceed with the study procedures. The master randomization list will be 
maintained at FHI 360 and will not be available to study staff. 
Randomization groups will be concealed in sequentially numbered, sealed opaque envelopes (SNOSE).  We 
will instruct study staff never to open an envelope until the participant has given consent to participate in 
the study, is found to be eligible for the study, and is available to start intervention and control study 
procedures. The opened randomization envelopes will be retained as source documents and will be kept 
under secure and restricted access to protect the confidentiality of the participants. 
This is an open-label study – neither study staff nor participants will be blinded to study treatment arms 
after the point of randomization. Nonetheless, strict policies will be in place to preserve randomization 
integrity. Randomization documentation will be stored in a secure location. Data recording, assessment of 

 
 
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the primary and secondary study outcomes, and other assessments will be blinded to treatment arm where 
possible.  
In-depth Interviews 
Participants 
IDIs will be conducted at the conclusion of the intervention sessions with a sub-set up to 36 purposely 
selected YLHIV participants (who are 18 years of age and older) assigned to the intervention group from in 
the original sample at the conclusion of the SMART Connection sessions.  The sample will include up to 12 
individuals per group who are classified as: 
• 
Having moderate/high participation in the group 
• 
Having low participation in the group 
• 
Having opted not to join the group to which they were assigned 
Participants in the on-line support groups will be categorized as having moderate/high participation or low 
participation, based on the assessment of the online support group facilitators based on participants' 
frequency of posts, likes, comments on posts, and private messages to the facilitator. Those who are 
categorized as moderate/high participation will be asked questions to explore their perspective (likes, 
dislikes and suggestions for improvement) on the intervention platform, intervention content, and the 
implementation of the three components (push informational messages, moderated group chats and 
unstructured access to peers and their counselor through the Facebook site). For those with low 
participation, we will explore reasons for non-participation and suggestions for changes, if any that could 
serve to enhance participation. We will also conduct IDIs with participants who were randomized to the 
intervention arm but did not join an online support group to explore reasons for non-participation and 
experiences with the study outcomes independently from the intervention. Within each of these three 
participant groups, we will purposely sample participants who have good retention in care and those who 
have not been retained in care or who have missed some clinic appointments. 
Data collection 
Responses to structured questionnaires will be recorded in electronic files on computer tablets. Contact 
information, including name, phone number, address, date of birth, sex, medical record number, and name 
and relationship for a second contact person, if available, will be recorded. All identifying information/ 
contact information will be recorded in a separate, password-protected file and only a unique study 
identification number will be recorded with all data collection instruments (structured questionnaire, clinical 
data abstraction form, in-depth interview responses). All interviews will be conducted in a private setting 
either onsite at the facility or offsite at a nearby location, per the participant’s preference. All interviews 
(structured or IDIs) will be conducted by trained data collectors. Informed consent forms and questionnaires 
will be translated into Oro, Ibibio and Efik, and available to be administered in English as well, per the 
participant’s preference. 
At six months and endline, the participant will be contacted during his/her regularly scheduled clinic 
appointment to complete the relevant questionnaire. If the participant misses the scheduled appointment 
by more than one week, the study staff may attempt to contact the participant and/or his/her parent using 
the contact information provided by the participant/participant’s parent up to three times over two weeks 
to reschedule the final interview and ask if the participant wishes to continue to take part in the research. 
The person who calls or visits the participant will not identify himself/herself as part of the study to avoid 
inadvertent breach of confidentiality. For the mid-course and endline interviews, interviews may be 
conducted by telephone if the participant is unable to return to the facility within 4 weeks of the scheduled 
interview. 

 
 
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After completion of the intervention sessions, in-depth interviews, using a semi-structured interview guide, 
will be conducted with up to 36 participants. We will conduct an additional round of IDIs with a sub-set of 8-
12 intervention arm participants at 12 months to explore sustainability. 
Structured questionnaires 
Participants will be asked to respond to structured questionnaires through face-to-face interviews 
conducted by trained interviewers using computer tablets prior to the launch of the intervention, after 
completing the intervention sessions and at the end of the study period. Data to be collected include: basic 
demographic information (e.g. sex, age, education level, relationship status (e.g. married, partnered, single), 
living arrangements (whether they live with a parent or guardian, how many people are in their household, 
and relationship to those people), as well as contact information (phone number, place of residence); HIV-
related information including how long since diagnosis, current ART regimen, last CD4 and viral load test 
date and results, disclosure status, self-reported adherence; social support measures covering emotional, 
instrumental, informational and network social support dimensions; factors associated with poor retention 
and adherence, including depression/anxiety, alcohol and other substance use, and perceived and 
experienced stigma; and access to and use of mobile telephones and social media applications. Forms will be 
administered at baseline and again at six months and endline, which will be 6 and 12 months after the 
intervention is initiated, respectively. Six-month and endline questionnaires will include additional, closed- 
and open-ended questions pertaining to intervention participation. Telephone interviews may be conducted 
in place of face-to-face interviews for participants who, after at least 2 attempts to schedule in-person 
interviews, are unable or unwilling to return to the clinic for interviews after the intervention and at the end 
of the study period. 
Clinical data 
A data abstraction sheet will be developed to abstract relevant clinical data for each study participant. 
Trained data collectors will abstract data periodically (approximately quarterly) through 15 months after 
enrollment. As noted, the form will only record the participant’s unique study ID for identification purposes. 
Data to be abstracted will include: date and results of CD4 cell counts and viral load tests; date of HIV 
diagnosis; date of ART initiation; WHO clinical stage at ART initiation; dates of ART refills; dates of ART clinic 
visits. 
Participation data 
Data from the group participation will be collected and analyzed using a social media analytics tool called 
Grytics (https://grytics.com/). We will collect data on a weekly basis per group on the number of active 
members, the number of posts, the number of comments, the number of reactions to posts by type (“wow,” 
“love,” “like,” “angry,” “haha,” and “sad”). We will also document the number and reason for personal 
messages to the group facilitator, such as question about side effects, question about appointment, etc. For 
messages, we will ask the facilitator to keep a log of messages indicating the date, time and main reason for 
contact. 
In-depth interviews 
IDIs will be conducted by trained interviewers, experienced in IDI administration, after obtaining informed 
consent. Once eligible participants are identified, the interviewer will contact the participant to request their 
participation in the interview and arrange a time to meet the participant at the health facility or another 
private location acceptable to the participant for the interview. The interviewer will audio-record the 
interview, in addition to taking notes during the interaction. The digital audio recording will then be 
translated and transcribed into a Microsoft Word file, which will be password protected and uploaded to the 
study SharePoint site for data analysis. A separate folder will be created on SharePoint with access limited to 
study staff within FHI 360. 
A second round of IDIs will be conducted with a subset of 8-12 intervention arm participants at 12 months to 
explore sustainability of intervention participation. 

 
 
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IDIs will also be carried out with all health facility and community-based organization (CBO) staff involved in 
intervention coordination or implementation at the conclusion of the intervention sessions. The aim of 
these interviews will be to explore experiences related to intervention implementation, challenges, if any, 
encountered and suggestions for improving the intervention to achieve greater participation. 
Cost data 
Data on costs for intervention training, materials, supplies and implementation will be extracted from study 
financial records by study staff and entered into an Excel spreadsheet. These costs will also include 
facilitator stipends, CBO supervisors to facilitators and monthly meetings for facilitators. To describe relative 
costs of in-person support groups, data will be extracted from SIDHAS financial records.  
Measures 
We will collect basic demographic information on participants (sex, age, marital/relationship status, 
education, occupation, religion) as well as background information on the participant’s HIV infection: when 
diagnosed, when started ART, disclosure of HIV status to others, viral load and CD4 testing. Additionally, we 
will collect data on psycho-social factors associated with poor retention and adherence, including 
depression/anxiety, alcohol and other substance use, and perceived and experienced stigma. 
The measures for which data will be collected are outlined below, by study objective. A summary of the 
measures and source of data, by objective, is found below in Table 1. 
Objective 1: To test the effectiveness of a structured online support group (SMART Connections) to 
retention in HIV services among YLHIV. 
Retention: This main outcome is defined as retention in clinical HIV services and on treatment. We will 
abstract data from the clinic electronic medical record system on date of all visits, which are typically 
monthly, to ART services between enrollment and the endline of this study.  
Retention is defined as having attended a scheduled HIV clinic visit within three months of the visit date. For 
our primary analysis, using a survival analysis approach, we will record the dates for all scheduled clinic visits 
for each participant, then follow the data up to three months from the date of the last visit attended. If a 
participant fails to return after a scheduled visit for more than three months, the date of the missed visit will 
be the date of loss to follow-up recorded, unless a death or transfer of service is documented. 
We will also report on the proportion of participants, by study arm, who are retained at 12 months after 
enrollment. To be considered retained in HIV services, an individual must, at 12 months after enrollment, 
have picked up his/her medication for his/her most recently scheduled clinical follow-up visit within 3 
months of the date when it was scheduled to take place. We will record, from the medical record, if a 
participant has knowingly enrolled in services elsewhere (transferred), in which case attempts to contact the 
participant will be made, if feasible; we will also record if the participant has died or has been recorded as 
lost to follow-up.  
In addition to clinic records, at the end of the study, personal contact information, including phone number 
and home address, gathered during study enrollment will be used to trace participants who do not return 
for endline interviews to determine if the person has transferred care elsewhere. If the person has 
transferred care, we will request the SIDHAS staff, who have access to clinic records in SIDHAS-supported 
facilities, to verify the patient has attended his/her 12-month appointment within the 3 -month timeframe. 
Objectives 2 and 3:  
2. To examine the effect of the online support group on social support, HIV knowledge and 
treatment literacy, and ART adherence among YLHIV. 
3. To test the potential mediating effect of social support on the relationship between the 
intervention and primary outcome. 

 
 
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Social support: To measure social support, we will use the Medical Outcomes Study – Social Support Survey 
(MOS-SSS).41 This scale, developed in the early 1990’s, has been used extensively in a number of different 
countries and with a variety of health outcomes, including HIV in China, Ireland, the US and in Ghana.42-50 
The MOS-SSS is a 19-item scale that covers the dimensions of emotional, information, affectionate and 
tangible social support in addition to positive social interaction. 
Adherence to anti-retroviral treatment: Adherence to ART will be measured through self-reported measures 
in the structured questionnaire of treatment adherence and challenges with taking medication as 
prescribed. In the study, we will measure self-reported adherence using the AIDS Clinical Trials Group 
adherence measure (AACTG baseline: http://caps.ucsf.edu/uploads/tools/surveys/pdf/2098.4186.pdf).51 
This validated measure has been widely used to measure adherence for research purposes. We will also 
extract viral load and CD4 cell count data from patient medical records.  
HIV Knowledge and Treatment Literacy: A set of 15 knowledge-based questions covering HIV transmission, 
diagnosis, treatment, and treatment monitoring have been developed based on topics covered in the 
Positive Connections curriculum. Each item is scored 1 if answered correctly and 0 if answered incorrectly. A 
total knowledge score is calculated based on the sum of the items with a possible range of 0 to 10. 
Additional psycho-social measures 
We will also gather data on key psycho-social factors that have been demonstrated to be associated with 
adherence and retention in services elsewhere: alcohol and other drug use, depression, and stigma.52 For 
alcohol use, we will use the AUDIT-C abbreviated, 3-item scale.53 The AUDIT-C is an abbreviated version of 
the 10-item Alcohol Use Disorders Identification Test (AUDIT) tool developed by the World Health 
Organization to measure harmful and hazardous alcohol drinking behaviors.54 For the AUDIT-C, each of the 
three items is scored on a 5-point scale (0-4), and the scores are totals across items for a final score that 
ranges from 0 to 12. A score of 3 or greater for women or a score of 4 or greater for men is indicative of 
harmful alcohol use.53 We will measure other drug use through an item adapted from the AACTG adherence 
questionnaire.51  
Depression will be measured using the 8 items from the Stanford Patient Education Research Center’s 
Patient Health Questionnaire Depression Scale (PHQ-8).55 The PHQ-8 asks respondents on how many days 
over the prior two weeks they experienced 8 possible symptoms, with response options of “not at all”=0, “a 
few days”= 1, “more than half the days”=2, and “most all of the days”=3. The score for each item is summed 
and a total score that ranges from 0 to 24 is assigned. Respondents who score 10-19 points are considered 
to have major depression and those who score 20 or more have severe depression.55 Finally, for HIV-related 
stigma, we will use a 12-item scale that was adapted by Reinius and colleagues from the 40-item HIV Stigma 
Scale.56 This shortened stigma scale covers four dimensions of stigma: personalized stigma, disclosure 
concerns, concerns about public attitudes, and negative self-image. Assessment of psychometric properties 
of the shortened scale revealed good validity and reliability as compared to the original scale.56 Each item is 
scored on a 4-point Likert-type scale and the scores added within dimensions with possible scores ranging 
from 3 to 12.56 A greater score indicates a greater level of perceived HIV-related stigma. 
Objective 4: To document the costs of the intervention and calculate the unit cost per YLHIV retained. 
Intervention costs will be computed from the perspective of the program (as opposed to the perspective of 
the beneficiary.) They will be descriptively compared to the costs of adolescent-focused, in-person support 
groups in the region. 
Cost data will include: costs associated with putting the intervention in place (training, materials, supplies, 
initial group meeting) and implementation (costs of cell phones, sim cards, airtime/data, facilitator stipend 
and staff time to purchase and distribute air time to participants). 
Objective 5: To document participant engagement and perspectives regarding the content and delivery of 
the intervention. 

 
 
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Participation/engagement – For this we will record if youth participate in the components of the 
intervention; which components have the greatest uptake, which the least. As noted above, we will collect 
data on a weekly basis per group on the number of active members, the number of posts, the number of 
comments, the number of reactions to posts by type (“wow,” “love,” “like,” “angry,” “haha,” and “sad”). We 
will also document the number and reason for personal messages to the group facilitator, such as question 
about side effects, question about appointment, etc. For messages, we will ask the facilitator to keep a log 
of message indicating the date, time and main reason for contact. 
At the conclusion of the intervention, we will select a subset of participants for IDIs to explore their 
perspectives with regard to intervention content and delivery.  
Objective 6: To document intervention content and fidelity by support group facilitators. At 6 months, once 
the intervention delivery is complete, we will analyze data from Grytics to evaluate whether facilitators were 
able to post push messages as outlined in the intervention guide. Timeliness and completion of each 
scheduled activity will be evaluated. Additionally, notes from facilitator meetings will be used to understand 
facilitators' experiences delivering the intervention.  
 
Table 2. Summary of key study measures by objective. 
Study objective 
Concept/variable 
Measures 
Source of data 
Objective 1; To test the 
effectiveness of a structured online 
support group to retention in HIV 
services among YLHIV. 
Retention in HIV 
services 
Dates of clinic visits during study 
 
Questions regarding clinic visits, 
missed visits, reasons for missing 
visits 
Medical record data 
 
Structured 
questionnaires. 
Objective 2: To examine the effect 
of the online support group on 
social support, HIV knowledge and 
treatment literacy, and ART 
adherence among YLHIV. 
Social support 
MOS-SSS items 
Structured baseline and 
endline participant 
questionnaires 
ART Adherence 
AACTG Adherence Assessment 
items 
 
Viral load 
Structured baseline and 
endline participant 
questionnaires 
Medical record data 
HIV-related 
Stigma 
12-item stigma scale 
Structured baseline and 
endline participant 
questionnaires 
Substance use 
AACTG Adherence Assessment 
items 
Structured baseline and 
endline participant 
questionnaires 
Objective 3: To test the potential 
mediating effect of social support 
on the relationship between the 
intervention and primary outcome. 
Treatment 
exposure 
Assignment to intervention or 
control 
Based on study 
assignment 
Social support 
MOS-SSS items 
Structured baseline and 
endline participant 
questionnaires 
Retention in HIV 
services 
Questions adapted from AACTG 
Adherence Assessment items 
 
Dates of clinic visits during study 
Structured baseline and 
endline participant 
questionnaires 
Medical record data 
Objective 4. To document the costs 
of the intervention and calculate 
the unit cost per YLHIV retained. 
Cost to put the 
intervention in 
place 
Training costs (travel, per diem, 
venue rental, materials) 
Study financial records 

 
 
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Intervention costs will also be 
descriptively compared to the 
costs of adolescent-focused, in-
person support groups in the 
region. 
 
 
Implementation 
costs 
Monthly facilitator meetings 
(transportation and refreshments) 
Facilitator stipend 
Equipment (phones) and supplies 
(airtime/data bundles) 
SIDHAS and study 
financial records 
Estimated in-
person support 
group costs 
Facilitator stipend 
Venue costs 
Transportation costs for facilitator 
and participants 
Refreshments 
Equipment/supplies for meetings 
SIDHAS financial records 
In-person support group 
reports (no individual-
level data) 
Objective 5: To document 
participant engagement and 
perspectives regarding the content 
and delivery of the intervention to 
inform scalability and 
sustainability. 
 
 
Engagement 
Number of sessions in which 
participants actively post 
comments or reply to comments. 
Number of comments per session. 
Grytics software 
Perspectives on 
content and 
delivery 
Perspectives on topic relevancy, 
clarity, usefulness. 
Perspectives on content structure 
(components of sessions). 
 
Structured interviews 
and IDIs 
Perspectives on 
content and 
delivery 
Perspectives on delivery 
frequency, facilitator engagement, 
medium of engagement. 
 
Structured interviews 
and IDIs 
Objective 6: To document 
implementation and fidelity 
 
 
Fidelity of 
implementation 
Ability to push out correct 
messages, hold regularly scheduled 
group chats as directed in 
intervention guide. 
 
Grytics software linked 
to Facebook groups 
 
Intervention 
delivery 
Perspectives on ease or difficulty 
delivering content as directed by 
manual. 
Perspectives on usefulness of 
facilitator manual to support 
implementation. 
Perspectives on frequency of 
delivery and time-burden required. 
Facilitator meeting notes 
Data Management and Analysis 
Data management 
Structured questionnaires 
Structured questionnaires will be programmed into electronic format using Open Data Kit (ODK) software 
and data will be collected on password protected computer tablets, then uploaded to a secure FHI 360 
server daily. Data on the tablets will be erased from the tablet once upload has been confirmed by the study 
analyst. The data will be stored in a password protected file on the secure server which is accessible only to 
study investigators. Data will be reviewed periodically during data collection for completeness and errors. 
Once data collection is complete, the final raw data set will be downloaded to FHI 360 study staff 
computers, which are also password protected, for final cleaning and analysis. Once the project is closed 
out, all data will be downloaded and stored in a FHI 360 SharePoint folder, and the server database will be 
deleted. A complete set of de-identified data will be made available and uploaded to a data-sharing site, 

 
 
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such as the USAID Development Data Library or similar open access database after completion and 
publication of study findings, no later than the end of the YouthPower Project contract. 
Clinical data 
A data abstraction form will be developed and programmed into computer tablets using ODK. These data 
will be entered into the tablets and uploaded to the secure server in the same manner as the structured 
questionnaires. 
Participation data 
Grytics permits users to collect use data from the Facebook groups for which they serve as administrators. 
For the purposes of this study, the group facilitator will be the primary administrator for the Facebook 
group. A study Facebook account will be registered to which only three study staff - the principal 
investigator, Lisa Dulli, the intervention design lead, Kate Plourde, and the lead quantitative data analyst, 
Kathleen Ridgeway - will have access. This study account will be listed as a co-administrator for each of the 
study Facebook groups. The study staff members will not engage in the groups; they will only run the weekly 
use analytics and download use data to a secure FHI 360 server.  Grytics does not allow the members’ 
usernames of the group to be displayed unless they opt-in. For this study, facilitators were asked to opt-in so 
we could differentiate between their activity and those of participants. All participant activity on the 
Facebook group is therefore anonymous. At the conclusion of the study, the Grytics account will be closed. 
No Facebook group data will remain on Grytics or on the study Facebook account; the only record will be 
the anonymous data on the FHI 360 server. 
In-depth interviews 
IDIs will be conducted by trained interviewers, with experience in IDI administration, after obtaining 
informed consent. The interviewer will audio-record the interview, in addition to taking notes during the 
interaction. The digital audio recording will then be translated and transcribed into a Microsoft Word file, 
which will be pass-word protected and uploaded to the study SharePoint site for data analysis. A separate 
folder will be created on SharePoint with access limited to study staff within FHI 360. Handwritten notes will 
be destroyed after being transcribed into electronic documents and verified by the contracted research 
organization. Audio-recordings will be destroyed once data analysis is complete. 
Cost data 
Information on costs will be collected using customized Excel spreadsheets.  These spreadsheets are 
designed to appear similar to activity-based budgeting formats familiar to most program staff.  
Analyses 
A detailed analysis plan will be developed and subjected to technical review and approval by the FHI 360 
Biostatistics department prior to analyses. As an overview, we describe the main analytical approaches here. 
Primary Objective 
The primary outcome for this study is retention HIV care. A participant will be considered to have been lost 
to HIV care if s/he has not picked up medication within 90 days of the last scheduled pick-up date. This 90-
day grace period is given at each pick-up time period. Our data collection period will extend to 15 months to 
maximize completeness of the 12-month retention data and account for any participant who consistently 
picks-up medication through month 11 and then misses their pick up in months 12 and 13, but is still 
considered retained in care because they pick up in month 14. Cases that can be confirmed to have died or 
transferred to a facility outside the study facilities and retention data cannot be obtained reliably will be 
considered censored. Kaplan-Meier cumulative retention probabilities will be reported with 95% confidence 
intervals and plotted by study group. The retention probabilities between the groups will be compared with 
a logrank test stratified by site with a two-sided alpha = 0.05. 
Secondarily, we will report on retention descriptively, examining lapses in care and return to treatment over 
the course of the 12-month follow-up. 

 
 
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Analysis plan for other objectives 
To examine the association between treatment exposure and secondary outcomes of social support, 
adherence and viral suppression, we will conduct significance testing using two-sided tests, with an alpha of 
0.05. To examine the relationship between treatment exposure and social support, a continuous variable, 
we will conduct a t-test. For adherence and viral suppression, both of which will be dichotomized, we will 
conduct chi-square tests. 
For the third objective, to examine the potential mediating effect of social support on the relationship 
between the intervention and the primary outcome, retention in care, we will use the Barron and Kenney 
approach 57.  Kenney and colleagues describe a 4-step strategy for testing mediation, which includes:  
1. Establish a statistically significant relationship between the independent variable (intervention) and 
the dependent variable (current modern contraceptive use) 
2. Establish a statistically significant relationship between the mediator (HBM variable) and the 
independent variable (intervention) 
3. Establish a statistically significant relationship between the mediator (HBM variable) and the 
dependent variable (current modern contraceptive use) 
4. Demonstrate that the relationship between the independent variable and the dependent variable is 
significantly reduced when the mediator is added to the model. The significance of the mediated 
effect can be assessed using a statistical procedure known as the Sobel test 58.     
To estimate the total costs for the intervention, we will use FHI 360’s intervention costing approach to 
measure costs of intervention activities.  FHI 360’s approach classifies activities according to three distinct 
phases: design/development, preparation for implementation, and implementation.  We will concentrate on 
the second and third phases, because costs of design and development activities are not repeated during 
scale-up.  Costs associated with “preparing for implementation” include training of facilitators and other 
direct costs of implementation such as printing and field logistics.  Costs of implementation are those 
associated with carrying out the activity.  
In-depth interviews 
As soon as possible after the IDIs are conducted, transcript text will be read carefully by the study 
investigators in order to: (1) ask any questions of the text that may be unclear; (2) point out areas in which 
interviewing and transcription techniques could be improved; and (3) identify recurrent themes and areas 
for future probing. Data-derived codes developed through inductive coding and retrieving will be used 
during analysis. A priori codes for retrieving text for key concepts related to the overall objectives also will 
be applied to the data. Investigators will determine a coding frame to be used based on the topic guides and 
the first few IDIs available for analysis. New codes will be added as necessary during transcript analysis. A 
qualitative data software program, such as QSR NVivo or a similar program, will be used to organize all 
qualitative data and prepare the data for analysis. Once all the transcripts have been coded, textual coding 
reports will be produced. Data reduction techniques will be used to examine codes in detail for sub-themes 
and patterns across the IDIs. Summary reports will be developed and recommendations for intervention 
adaptations will be made.  
Study Management and Study Team Roles 
Dr. Lisa Dulli, Scientist II, FHI 360 Health Services Research will serve as Principal Investigator (PI) for this 
research. She will be responsible for overall fiscal and administrative, issues as well as study development 
and implementation, and for overseeing analyses and reporting of study results. Catherine Packer, Research 
Associate II, FHI 360 will serve as study manager and support Dulli with logistical, budgeting, administrative 
issues. She will also provide quantitative and qualitative data analysis support to Kathleen Ridgeway, 
Research Associate I, FHI 360, who will serve as lead analyst for the study. Dr. Donna McCarraher, Director 

 
 
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Reproductive, Mother, Newborn and Child Health (RMNCH), FHI 360, will provide topical expertise for YLHIV 
to the study. Dr. Mario Chen will lead data analyses and oversee quantitative data analyses conducted by 
analysts. In Nigeria, a local study coordinator FHI 360, will be hired to support to both intervention and 
study implementation by serving as the primary point of contact for FHI 360 Nigeria and liaising with both 
the implementing organizations and data collection firm. Kate Plourde, Technical Officer, FHI 360 is leading 
development of the m/eHealth intervention, including adaptation of the Positive Connections support group 
curriculum for an online medium. Dr. Tosin Idaboh provides overall technical support to the study on behalf 
of the SIDHAS project. Study recruitment, enrollment and data collection activities have been contracted to 
the University of Ibadan’s Center for Population and Reproductive Health (CPRH). 
The CPRH study manager will be responsible for overseeing day-to-day data collection activities and for 
monitoring data quality and integrity. Both the CPRH study manager and the FHI 360 study coordinator will 
be responsible for alerting the FHI 360 PI to any protocol violations, adverse events or social harms. The PI 
and the FHI 360 study manager will ensure proper reporting of any protocol violations, adverse events or 
social harms to all respective ethics committees per standard policies and procedures. 
Ethical Issues 
This study aims to test the effectiveness of an mHealth intervention to increase retention in care and 
improve adherence to ART among youth, ages 15 to 24 years, living with HIV. Prior to study implementation, 
all study staff, including individuals who participate in data collection activities or intervention 
implementation, will have completed an approved research ethics training curriculum. The study will be 
submitted for ethical review and received approval from Research Ethics Committees in Calabar State, Akwa 
Ibom State, and FHI 360’s Protection of Human Subjects Committee (PHSC) prior to collecting data. 
Considerations for inclusion of minors 
Minors between the ages of 15 to 17 years will be actively recruited into this study based on the need for 
effective interventions to improve retention in HIV treatment services and ART adherence among this age 
group. 
Informed consent 
All participants will be provided information on the intervention, on the scope and nature of the interviews 
to be conducted, the medical record data that will be recorded and the intervention data that will collected. 
We will obtain written informed consent to participate before any data collection is conducted, including 
data collection through Facebook groups, if they agree to participate. If the youth is less than 18 years of age 
and not emancipated, we will seek parental consent to participate and youth assent. If parental consent is 
required, the study staff will request that the potential participant’s parent/guardian be contacted to 
provide informed consent. If the potential participant refuses, he/she will not be eligible to participate. If the 
potential participant accepts, the study staff will ask that the parent/guardian come to the health facility for 
the consent process. If the potential participant and parent/guardian prefer, the study staff can arrange to 
meet the parent at the patient’s home. In cases where youth are younger than 18 years of age, if the youth 
is an emancipated minor through marriage or living independently from his/her parents/guardians, we will 
seek informed consent directly from the participant. It is important to note that the informed consent forms 
(including parental consent and youth assent) will not contain a reference to HIV for privacy purposes since 
a copy will be given to the participant/parent; however, both the provider who refers the youth to the study 
staff and the study staff who gains informed consent and interviews the participant will verbally tell the 
individual that the study is for youth living with HIV and the support group that is part of the intervention is 
to support YLHIV.  
Participants who are invited for in-depth interviews will be at least 18 years old. The study staff will conduct 
an abbreviated oral consent form to obtain the participants’ oral informed consent to participate in this 

 
 
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interview as well as to be audio-recorded. Participants who do not consent to audio-recording will not be 
interviewed.  
Risks to Participation 
We do not anticipate any serious physical, mental, or social risks due to participation in this research. The 
greatest risk of participation in the study is inadvertent breach of confidentiality. Measures will be taken to 
protect the confidentiality of the participants. For data collection – all interviews will be conducted in a 
private setting, data will be recorded on password protected devices, uploaded to a secure server and all 
data will be de-identified, with a separate file containing identifying information kept on a separate, 
password protected computer.  
With regard to participation in the intervention under study, participants will be offered telephones to 
participate, but the participant can refuse the phone if he or she thinks it would cause concern among 
others. If a phone is lost, stolen or broken, it will not be replaced. Also, the phones will be one of the more 
typical entry-level smartphones sold to Nigerian consumers that meets our intervention needs so that those 
who have the phone won’t be identified with the intervention or research.  
The virtual support groups, as with face-to-face groups commonly implemented, carry some risk that fellow 
group members or facilitators could disclose personal information to people outside of the group. 
Facilitators will be trained on issues of confidentiality, which is part of the curriculum being implemented. 
Group members will be brought together to set ground rules for participation which will include at a 
minimum the need to keep group discussions confidential. In terms of the platform to be used for 
communication among group members, we will use Facebook which provides secret groups that are not 
searchable or joinable by outsiders. Group membership will be strictly controlled by the main group 
administrator who is the facilitator. Group members will be instructed in logging into the application, logging 
out after use to prevent others with access to their phone from seeing the group and in locking their phones 
using its security features to avoid others gaining access to the phone without their permission. They will be 
instructed not to save passwords on their phone with a password manager, or to share their Facebook 
password with others. In the event that the facilitator or other group member(s) learn that a group member 
has intentionally permitted access to the Facebook group posts to a person outside the group, the facilitator 
will immediately remove the individual from the group until he/she can determine if the breach of 
confidentiality has actually taken place. If it is determined that the breach did in fact occur, then the person 
will not be invited back to be a member of the Facebook group and will be permanently blocked to protect 
the privacy of the other members. The facilitator and local study coordinator, would bring together all other 
members of the group, or those who may have been affected by the breach, in an in-person group to discuss 
the breach and how to handle the situation. Alternately, if the breach only affects one or a few members, 
the study staff and facilitator may contact the participants individually. If a participant prefers, the facilitator 
may meet with them individually instead of with the full group. Any such incident would be reported as soon 
as possible to both the local and FHI 360 ethics committees, per FHI 360 PHSC policy. 
With regard to interview procedures, it is possible that some participants may be uncomfortable when 
asked about sensitive topics during the structured or in-depth interviews. To minimize the potential for any 
adverse events, study staff will conduct interviews in a private location. As part of the consent process, 
participants will be informed that they can refuse to answer any question and they can terminate an 
interview or their participation in the study at any time without penalty. 
Additionally, in the case that a participant discloses a need for psychosocial support during an interview, 
referrals for additional psychosocial supportive services or other health services will be made as needed. A 
list of resources will be developed for the study sites. If these services are not available or accessible to the 
study participants, an alternative strategy will be developed to provide supportive services. In case of an 
emergency, such as disclosure of suicidal ideation or severe depression, the potential participant will be 
referred immediately to the health care provider on site. Additionally, monthly debriefings with facilitators 

 
 
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will be held throughout the study to enable staff to share experiences and support each other. They will also 
give feedback on how participants are receiving the intervention, any related questions, and share 
techniques for increasing rapport and gathering accurate information.  
Anticipated benefits to participation 
Participants in the study may directly benefit from participating in the mHealth intervention. The 
intervention is designed to lead to improvements in HIV treatment retention and adherence that could lead 
to improved health. Additionally, the intervention is designed to increase access to social support from other 
YLHIV, a problem for many YLHIV who fear disclosing their HIV status to others. Participants enrolled in the 
online support groups will be free to continue with those groups, if they choose, at the conclusion of the 
study. At the conclusion of the feasibility study, all Facebook groups continued by participants’ choice. 
Compensation 
Although cell phone ownership is high in Nigeria (89% in 2015)31, it is possible that youth who participate in 
this study may not have access to their own phones and may share them with others, such as a sibling or a 
parent. Because this study is an efficacy study to see if YLHIV who have access to the intervention 
experience better outcomes than those who do not access the intervention, the study will provide each 
YLHIV participant with a cellular phone for participation that he/she may keep at the end of the study. The 
phones that will be provided will be consistent with typical phones found in the community and will have no 
distinguishing characteristic that would identify the phone as part of a study or intervention. The value of 
the phones to be provided is estimated to be between 20,000 to 25,000 Nigerian Naira (approximately 
(US$55-$70). In addition to the telephone, participants will receive 1000 Naira (US$3) of data per month and 
a travel reimbursement of 1,500 Naira (US$4.5) for each trip to participate in each interview (baseline, mid-
course and endline) and for the initial study group meeting. The travel reimbursement of 1,500 Naira is a 
standard rate set by the SIDHAS project. No additional compensation will be provided to parents for their 
permission for their child to participate. 
Participant privacy and confidentiality 
The collection of identifying information is required for this study. Personal identifiers (name, date of birth, 
telephone number, medical record number, address, phone number and phone number for a next of 
kin/additional contact) will be recorded in a separate, password-protected file with access only by study 
investigators and study staff. These will be associated with unique study identifiers, which will be the only 
identification recorded on data collection instruments. Once data collection, cleaning and data analysis are 
complete, the file containing the identifying information will be destroyed, leaving only a final, de-identified 
dataset. Handwritten notes taken during the in-depth interviews will be destroyed after being transcribed 
into electronic documents and verified by the contracted research organization. Audio-recordings will be 
destroyed once data analysis is complete, leaving a final de-identified interview transcript. 
Anticipated Outputs and Results Dissemination 
Findings from this research will be disseminated in a number of ways. Results will be shared with the SIDHAS 
project and USAID in Nigeria to allow for integration of findings into USAID-supported HIV care and 
treatment activities. Findings will also be shared with state and national stakeholders to inform future policy 
and practices related to HIV care and treatment services for YLHIV in Nigeria. A dissemination meeting is 
planned for all interested state, national and international stakeholders in Nigeria. 
We will also disseminate results internationally by submitting abstracts on the work to international 
conferences and publishing one or more manuscripts in peer-reviewed journals. 

 
 
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Timeline: 
 
2018 
2019 
2020 
 Activity 
Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr 
USAID approval 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FHI 360 Ethics Committee review 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Akwa Ibom, Cross River and National 
EC reviews 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data collector training 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study enrollment and baseline data 
collection 
 
 
 
 
 
 
 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention implementation 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Mid-course data collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Endline data collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X1 
X1 
X1 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Results dissemination in-country 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Manuscript for publication 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
1. Three months will be allocated to gather data on retention from clinical records, because LTF is defined as having missed an appointment by 3 months. 
 
 
 
 

 
 
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Appendix 1: SIDHAS-support ART standard services for YLHIV 
ART services targeting HIV-positive youth in Nigeria. (SIDHAS 2018) 
*Steps in Service Delivery for the Pediatric and Youth Viral Load Suppression Tracking 
<1 – 9 years 
10 – 15 years 
15 – 19 years1 
Each backstop/organizational focal person collates pediatric and youth clients’ information in supported facilities 
Assign each youth and pediatric client to specific case managers for differentiated care. 
At arrival to the health facility, HCWs triage the pediatric and youth clients into three groups outlined above. 
Identify a primary committed parent/care giver and update their contact details. 
Provide Intensified Adherence Support during the first 4 weeks of treatment initiation. 
Where possible, see the ‘family as 
one visitor’ and not make the 
family attend separate clinics 
even when appointments are 
given for the same day. 
Younger youth’ specific adherence challenges 
(e.g. taking medication at school; addressing 
why they alone are taking medication with 
siblings; rejecting medication due to bad taste; 
forgetting to take medication, etc.) and work 
with the caregivers to suggest how to address 
these issues.   
Older youth’ specific adherence 
challenges (e.g. taking medication 
at school/ away from home);  
Address transition to adulthood 
concerns. 
Link the children and their caregivers to family adherence support groups 
Link families to community 
support services including 
enrolling in the SIDHAS OVC Care 
and Support program in scale-up 
and sustained-plus LGAs 
Link families to community support services 
including enrolling in the SIDHAS OVC Care 
and Support program in scale-up and 
sustained-plus LGAs 
Link youth to facilitated youth-
specific support groups using 
modules/sessions from the 
‘’Positive Connections Manual.’’ 
Provide ongoing adherence support using: Adherence Support Calendar, phone calls, SMS reminders and home visits. 
Review viral load (VL) status for all pediatric and youth clients at EVERY facility visit. 
Enhanced adherence counselling for caregivers and youth with unsuppressed viral load 
Drug and Therapeutic Committee pays attention to treatment for pediatric and youth clients 
Conduct monthly data review of retention and VL status of the pediatric and youth clients 
1. All text highlighted in yellow are activities targeted to YLHIV enrolled in this study. 
 
 
 

 
 
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Appendix 2: Facebook data policy 
Appendix 3: Safety at Facebook 
Appendix 4: What are the privacy settings for groups? 
Appendix 5: How do I remove or block someone from a group? 
 
*Appendices in separate files.

 
 
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