Game Changers: Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda
Phase: NA
Conditions: HIV
Sponsor: RAND

 
 
 
 
 
 
 
 
 
 
 
 
Game Changers: Pilot Intervention to Empower HIV Clients as 
Prevention Advocates in Uganda 
 
November 13, 2018

PROTOCOL SUMMARY 
1. Background and Rationale 
Stagnant, high HIV prevalence in Uganda calls for innovative approaches to prevention. Uganda, 
as elsewhere in sub-Saharan Africa, has a generalized HIV epidemic with new infections caused 
by heterosexual sex (~80%) or mother-to-child transmission (~20%), and <1% due to 
homosexual sex, blood transfusions or other causes. HIV prevalence has stagnated at ~7% since 
2005, with a continued annual incidence of about 130,000.  
Empowering people living with HIV (PLWH) to be change agents for HIV prevention draws on 
the full armament of existing prevention paradigms. Prevention for Positives and Treatment as 
Prevention have targeted the risk and treatment behaviors of PLWH, but current paradigms do 
not take advantage of the potential for PLWH to be change agents for HIV prevention within 
their social networks. Receipt of HIV care often comes with renewed health and a sense of 
community and support from HIV-positive peers, and our research suggests that most HIV-
positive clients actively encourage friends and family to seek HIV testing and care, and reduce 
risk behavior. Drawing on theoretical frameworks for network-based social influence, and 
established relevant interventions, this study will pilot test Game Changers - an intervention 
that aims to empower and mobilize PLWH to be agents for HIV prevention and behavioral 
change in their social networks.  
2. Objectives 
The primary objective of this study is to assess feasibility, acceptability, and preliminary 
intervention effects of the Game Changers Intervention on: a) protective behavior of PLWH 
(condom use, number of partners, engagement in HIV care, ART adherence); and b) diffusion of 
prevention messages across the network, as assessed by the content and extent of 
communication with network members about protective behaviors (condom use, number of 
partners, HIV testing, engagement in HIV care, circumcision), HIV disclosure, and HIV stigma. 
3. Study Design 
We will screen approximately 500 PLWH at the Infectious Disease Institute (IDI) clinic to arrive 
at a sample of 96 participants who will be randomized to intervention or wait-list control (each 
evenly stratified by gender). There will be 4 gender-specific intervention groups and one 
control. The intervention consists of 6 workshops, which will occur approximately every other 
week. Participants will be asked to complete a workshop evaluation form after each workshop. 
Participants will be interviewed at baseline, 3-4 months after baseline, and again 6-7 months 
after baseline. The wait-list control will receive the intervention upon completion of the final 
follow-up assessment has been completed by all intervention groups. 

Participants will be asked to recruit 1-3 of their social network members to participate in three 
interviews. We expect to screen approximately 180 social network members to arrive at 90 
participants. 
4. Methods 
Screening/Recruitment 
There will be one screening/recruitment procedure for all PLWH participant-related 
procedures. The coordinator (who will be part of the clinic staff) will obtain the list of eligible 
clients scheduled for clinic visits during the recruitment period and will approach these 
individuals in the waiting room while they wait to see their provider to inform them of the 
study and assess their interest in participating. Alternatively, the coordinator will be at the clinic 
during days/times when potential participants are expected to be there. When clients are 
screened individually by the coordinator, they will be informed of the eligibility criteria and the 
legal risks of participation if they engage in same-sex sexual behavior or commercial sex work. 
Clients who express interest will be initially screened for age (to ensure they are 18 years of age 
or older), sex (to ensure adherence to the strata described above), length of time in care, and 
having disclosed serostatus to at least one person. Clients will then be given an information 
sheet and consent form that explains the project in detail. They will be given the option to 
provide signed consent to participate at the clinic that day, or to take the materials home and 
consider, with instructions to return the signed consent form to the coordinator if they are 
interested. This allows gay clients to withdraw their interest without disclosing their sexuality. 
Clients will be assured that all information collected is confidential, and no identifying 
information will be collected and stored unless the person is eligible and enrolls in the study.  
Procedures 
Participants will be randomized to be in the Game Changers program or in the wait-list control 
condition. The Game Changers program will consist of 6 workshops conducted by trained IDI 
personnel. Stigma reduction and self-acceptance, comfort and competence with HIV disclosure, 
and healthy, positive living, form the foundation for effective prevention advocacy, and are the 
focus of the initial workshops. With the foundation set by the first few workshops, the last few 
workshops provide participants with skills, confidence and support for engaging in prevention 
advocacy with members of their network, and with education about tailoring messages.  
The 6 workshops will be implemented over about three months. Each workshop will last about 
2 hours and will be facilitated by 1-2 trained counselors with experience conducting group 
trainings and working with people living with HIV. The workshops will be administered in a 
group format to facilitate an interactive social process, social reinforcement, modeling, role-

plays and other interactive components of skills building; groups are most effective in 
developing self-identity as members of a community in which members rely on each other for 
support. A workshop evaluation survey will be conducted at the conclusion of each workshop.  
PLWH interview and social network assessments will be conducted by trained IDI personnel. 
The interview and social network assessment both will be administered in a single session in 
either English or Luganda as preferred by the participant. The first interview will last 
approximately 2.5 hours, and the second two interviews will last approximately 2 hours. 
The interviews will collect information about participant demographics; engagement with HIV 
care, prevention advocacy; knowledge/beliefs about and adherence to HIV medication; HIV-
related self-efficacy; HIV status disclosure; discrimination and stigma; social support; physical 
and mental health status; alcohol use; and relationship status and sexual behavior. During the 
social network assessment portion, participants will be asked to list 20 adults (18+ years) with 
whom they have had contact within the preceding year (e.g., friends, family, other community 
members). We will collect first name and last initial for each social network member to avoid 
the potential for confusing individuals who might have the same first and last initial, and to 
assist with linking network member data across assessments (to assess network change over 
time). For each social network member listed we will collect information about demographics; 
perceived serostatus; description of the relationship between the PLWH participant and the 
individual; PLWH participant’s engagement in prevention advocacy with the individual; social 
support provided by the individual; and the individual’s expression of HIV-related stigma. We 
will also ask for a description of how often individuals listed in the social network assessment 
interact with each other. 
Interview data and social network assessment data will be collected using an offline version of 
EgoWeb. Hard and soft copies of raw data, including participant identifiable information will be 
kept at IDI, and only computer files with de-identified data will be kept at RAND. The IDI study 
coordinator will keep a linking file that matches study IDs with participant names. The linking 
file will be stored separately from research data. Interview and network assessment data will 
be exported to transmittable files (e.g., Excel), and then the study coordinator will remove 
identifying information and insert study IDs into this file prior to transmittal to RAND. The file 
will be transmitted to RAND via SFTP, after which it will be moved to a secure RAND server and 
accessible to authorized personnel only. 
Social network member interviews will be conducted by trained IDI personnel. The interview 
will be administered in either English or Luganda as preferred by the participant. The first 
interview will last approximately 2 hours, and the second two interviews will last approximately 

1-2 hours. These interviews will assess participants HIV protective behaviors (e.g., condom use) 
and receipt of prevention advocacy from the intervention participant. 
Interview data will be will be collected using an offline version of EgoWeb. Hard and soft copies 
of raw data, including participant identifiable information will be kept at IDI, and only computer 
files with de-identified data will be kept at RAND. The IDI study coordinator will keep a linking 
file that matches study IDs with participant names. The linking file will be stored separately 
from research data. Interview data will be exported to transmittable files (e.g., Excel), and then 
the study coordinator will remove identifying information and insert study IDs into this file prior 
to transmittal to RAND. The file will be transmitted to RAND via SFTP, and will be accessible to 
authorized personnel only. 
Focus groups will occur at the conclusion of the intervention, and topics will include 
participants’ overall attitudes about the program, the facilitators, and different program 
activities, as well as how the program might be improved. We will conduct 5 groups, one for 
each intervention group, and 1 for the wait-list control group (after wait-list control participants 
receive the intervention).  
The groups will be facilitated using a structured guide of topical areas and questions. Open-
ended questions will be asked before probing questions to avoid biasing responses. The initial 
open-ended format allows for exploring new leads and related topics and generates rich 
personal narratives. Standard probes (verification; compare and contrast) will be used. 
Facilitator training will be conducted by Bogart and Matovu, and will cover the discussion guide, 
sensitivity issues, and confidentiality. Each focus group will last ~60 minutes.  
Note that participants may be called or texted as a reminder about the focus group session, if 
they provide their contact information to the interviewer. 
Focus groups will be audio-recorded and transcribed. Before beginning the session, the 
facilitator will assign numbers to participants and ask that they use these numbers to identify 
themselves and others in the group when speaking. As a result, audio recordings of the focus 
groups will have no identifying information, will be stored on a password-protected, encrypted 
file, and then destroyed once a transcript has been completed (within one week of 
administration). Transcripts will be transmitted to RAND via SFTP, after which they will be 
moved to a secure RAND server and accessible to authorized personnel only. Any hardcopy 
notes or other files resulting from the focus groups will be retained by IDI. 
Medical chart data obtained by RAND will include date of HIV diagnosis, last two CD4 counts 
and HIV viral loads, and prescribed HIV medication, and will be provided by the IDI clinic where 
PLWH participants receive care and will be recruited for this study (IDI is the main clinical 

referral center for HIV at Mulago Hospital, and manages these medical charts). Hard and soft 
copies of raw data, including participant identifiable information will be kept at IDI, and only 
computer files with de-identified data will be kept at RAND. The IDI study coordinator will keep 
a linking file that matches study IDs with participant names. The linking file will be stored 
separately from research data. The study coordinator will remove identifying information and 
insert study IDs into this file prior to transmittal to RAND. The file will be transmitted to RAND 
via SFTP, after which it will be moved to a secure RAND server and accessible to authorized 
personnel only. Medical chart data will be merged with other datasets using the study ID. 
Workshop evaluation surveys will be administered to participants by IDI personnel at the end 
of each workshop to elicit data on usefulness of the workshop, comfort with specific exercises, 
and ideas for improvement. No identifying information will be collected in this survey.  
Survey data will be entered into a spreadsheet and transmitted to RAND via SFTP. If onsite data 
entry is not possible, scanned copies of the surveys will be transmitted to RAND via SFTP. Any 
hardcopy files resulting from the survey will be retained by IDI. 
5. Statistical Analysis 
We will primarily use an intent-to-treat approach, with secondary analyses involving study 
completers. In addition to comparing the arms at each time interval, we will apply generalized 
mixed models (linear for continuous or ordinal outcomes; logistic for binary outcomes) to our 
repeated-measures data to examine how intervention effects change over time, using an 
indicator for study arm, an ordinal indicator of time, and time by arm interaction to indicate 
whether change differs between the arms. 
Aim 1: To assess feasibility and acceptance of the intervention, we will examine recruitment (# 
who sign up as interested in participating each recruitment day) and retention, workshop 
attendance (# who attend all workshops), and participant feedback elicited in the process 
measures (ratings of benefit; recommendation to peers). We will also compare the 
characteristics of the participants with that of the larger clinic population using routine data 
collected by IDI in order to assess the degree of selection bias caused by our recruitment 
strategy. 
Aim 2: To assess preliminary intervention effects on the outcomes (protective behavior of the 
HIV-positive clients: condom use, number of partners, engagement in HIV care, ART 
adherence), and diffusion of prevention messages across the network (content and extent of 
communication with network members about protective behaviors, including condom use, 
number of partners, HIV testing, engagement in HIV care, circumcision; HIV disclosure; and HIV 
stigma), we will primarily use an intent-to-treat approach, with secondary analyses involving 

study completers. In addition to comparing the arms at each time interval, we will apply 
generalized mixed models (linear for continuous or ordinal outcomes; logistic for binary 
outcomes) to our repeated-measures data to examine how intervention effects change over 
time, using an indicator for study arm, an ordinal indicator of time, and time by arm interaction 
to indicate whether change differs between the arms. A random-effects approach allows us to 
incorporate the heterogeneity among participants. We will use imputation for item 
nonresponse and account for non-random dropouts using logistic regressions that assign 
weights to retained participants that are inversely proportionate to the predicted probability of 
the participant being retained; if dropout is random, analyses will incorporate design effects 
when calculating standard errors and significance tests. With the intervention administered in 
groups, these analyses need to account for clustering of the data; however, the number of 
groups receiving the intervention is too small to reliably estimate the ICC to adjust standard 
errors; hence, we will use standard regression methods and explore the sensitivity of 
significance levels and conclusions to a range of plausible ICC values (.005 to .05) for the 
outcomes. We will also control for and examine interaction effects with intervention process 
variables (e.g., number of workshops completed), participant characteristics (e.g., ART status, 
gender, age), and alter characteristics (e.g., position in the network, HIV status, knowledge of 
ego’s HIV status). This will enable us to address Aim 3, to explore the context of prevention 
advocacy, including differentiating types of alters who received more, versus less, prevention 
advocacy, as well as characteristics of participants who engaged in more prevention advocacy 
throughout the network, to a larger number of alters.