A Gender Transformative Implementation Strategy With Providers to Improve HIV
Phase: NA
Conditions: HIV
Sponsor: The University of Texas at San Antonio

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Study Protocol and Statistical Analysis Plan 
Clinicaltrials.gov ID: NCT05178979 
Unique Protocol ID: 
K01MH121663-01A1 
Secondary IDs: 
1K01MH121663-01A1 [U.S. NIH Grant/Contract Award Number] 
Title: 
A Gender Transformative Implementation Strategy With Providers to 
Improve HIV Outcomes in Uganda 
Protocol date:  
11 July 2023 (final version date of approved IRB protocol) 
PIs: 
 
 
Katelyn M. Sileo  
Contact PI: 
 
Katelyn M. Sileo, BC, sileoka@bc.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Contents 
Inclusion criteria ......................................................................................................................................... 3 
Recruitment & Sampling ........................................................................................................................... 3 
Data collection ............................................................................................................................................ 4 
Questionnaires ....................................................................................................................................... 4 
Process Data .......................................................................................................................................... 5 
Data management ..................................................................................................................................... 6 
Qualitative data ...................................................................................................................................... 6 
Quantitative data .................................................................................................................................... 6 
Data safety monitoring plan ..................................................................................................................... 7 
Adverse events ...................................................................................................................................... 7 
Training of the RAs/Facilitators ............................................................................................................... 8 
Training of research assistants ............................................................................................................ 8 
Training of intervention facilitators ...................................................................................................... 8 
Statistical Analysis Plan ............................................................................................................................ 9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Inclusion criteria 
 
Provider cohort for training intervention, assessment, and exit focus groups (intervention 
trial). We will recruit providers for participation in our intervention trial for the provider training 
from the two selected clinics. The goal is to recruit the entire population of providers at each of 
the two clinics, which is approximately 20-35 providers per clinic (Luwero Hospital, Mityana 
Hospital, Kalagala HCIV and Namayumba HCIV) for participation. This cohort will include all HIV 
care providers at the 4 selected clinics, including: medical officers, clinical officers, HIV nurses, 
midwife, linkage facilitators, and counselors. These participants will be 18 years of age or older 
and fluent in English or Luganda. 
 
Patient cohort assessment (intervention trial). In addition to the assessment of the cohort of 
~80-140 HIV providers, we will obtain additional data on the impact of the provider training on 
patient outcomes including quality of care, patient satisfaction, clinic attendance, ART adherence, 
and viral load (from patient clinic records) by assessing 240 (60 per treatment facility, gender 
balanced) purposively sampled patients at baseline, 6-, and 12-month follow-up.  
 
Eligibility includes:  
1. HIV-infected; 
2. enrolled in care at the clinic of recruitment; 
3. pre-ART (newly diagnosed) or newly initiated on ART (within 1 year) or struggling with 
treatment adherence, defined in two ways:  
a. most recent viral load results unsuppressed as assessed through clinic records 
b. or self-reported non-adherence as by the Adult AIDS Clinical Trials Group 
(AACTG) scale 4-day adherence recall questions. This scale has demonstrated 
good construct validity in Uganda and strong correlations with viral load; 
4. 18 years of age or an emancipated minor; 
5. fluent in Luganda or English. 
Recruitment & Sampling 
 
Provider cohort for training intervention, assessment, and exit focus groups (intervention 
trial). Once research staff are trained and our two clinics have been randomly assigned as 
intervention or control arm, we will recruit providers for participation in our intervention trial for the 
provider training. The goal is to recruit the entire population of providers at each of the four clinics, 
which is approximately 20-35 providers per clinic (Luwero Hospital, Mityana Hospital, Kalagala 
HCIV, and Namayumba HCIV) for participation; approximately 35 at each hospital and 25 at each 
HCIV (total: 80-140). With support from Mildmay Uganda (see Letter of Support), we will generate 
support for the training first in the broader Health Districts (with medical superintendents and 
District Health Officers) through in-person meetings and garnering their feedback on the 
intervention through invitations to serve on/make recommendations for a “Training Steering 
Committee.” After District support is attained, we will then conduct facility mobilization with an in-
person presentation of the goals research study at each of the four clinics. Eligibility for providers 
includes being an HIV care provider at one of the four selected clinics. After the larger facility 

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mobilization meeting, the research assistant will meet one-on-one with HIV providers to 
individually inform them of the study, allow them to ask any questions in a private space, and 
obtain written informed consent. Though we aim to recruit all HIV providers at each clinic for 
participation, any provider can decline to participate. The informed consent process will include 
consent for both participation in the provider training, baseline, 6- and 12-month assessments, 
and an exit focus group. To mask the randomization of intervention and control, we will consent 
participants for participation in all aspects of the training. 
 
Patient cohort assessment (intervention trial). In addition to the assessment of the cohort of 
~140 HIV providers, we will obtain additional data on the impact of the provider training on patient 
outcomes including quality of care, patient satisfaction, clinic attendance, ART adherence, and 
viral load (from patient clinic records) by assessing 240 (60 per clinic, gender balanced) 
purposively sampled patients at baseline, 6- and 12-month follow-up. Patients will be non-
randomly approached when presenting to care by a Research Assistant based on a review of 
clinic records. After being referred by a clinician, our research assistant will inform individuals of 
the study and assess eligibility using an eligibility screening tool. No identifying information will be 
recorded during the eligibility screening. If eligibility is met and the patient would like to participate, 
the research assistant will obtain written informed consent and collect patients’ contact 
information (for follow-up reminders) and conduct the baseline questionnaire in the clinic or 
another agreed upon location. 
Data collection 
Questionnaires  
For the provider cohorts randomized to the Intervention clinics, the chronological activities 
include: enrollment; baseline interview immediately after enrollment; participation in ~21 hours of 
intervention content; follow-up assessments at 6-months and 12-months follow-up; one exit focus 
group post-intervention. Each data collection activity and its duration is detailed below: 
• 
Baseline provider assessment (for all provider participants). After the informed consent 
process a one-on-one interview (~25 minutes) using a computerized structured questionnaire 
in the clinic or another agreed upon location will be conducted with providers at both clinics. 
The questionnaire will collect demographic information and measures to assess provider 
outcomes. The total duration of participation for the baseline survey is approximately 25 
minutes. 
• 
6-, and 12-, month follow-up provider assessments (all provider participants). Research 
Assistants will conduct the 2 follow up interviews using an individual structured interviewer-
administered computer-based interview in the clinic or another agreed upon location for 
patient and providers. Providers have the option to complete these assessments over the 
telephone only if they have transferred to working at another clinic and cannot be reached in 
person. The follow-up questionnaires will serve as a measure of intervention effects on 
provider’s gender equitable attitudes and gender awareness and other related constructs (see 
Measures). This questionnaire is approximately 25 minutes per time point. Across the 2 
assessments, the total duration for survey participation is approximately 50 minutes. 

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For the patient cohort (n=240) enrolled in the intervention and control clinics. To assess 
the effect of the provider training on patient-level outcomes, we will assess change overtime in 
patient outcomes in a cohort of HIV patients enrolled at the 2 clinics. These patients do not receive 
any intervention, but will participate in an assessment across 3 time-points (following the same 
schedule as the provider assessment). They will also agree to a review and data extraction of 
health information from of their HIV clinic records at each time point.  
• 
Baseline patient assessment (all patient participants). HIV patients referred to the 
study and interested in participating will first answer a brief set of questions to assess 
enrollment. No data will be recorded at this time. If eligible and interested, we will obtain 
written informed consent before continuing with the baseline questionnaire. Using a 
computerized structured questionnaire, a research assistant will conduct the survey in the 
clinic or another agreed upon location at both clinics. The questionnaire will collect 
demographic information and measures to assess patient outcomes related to HIV care 
engagement (e.g., clinic attendance, medication adherence, patient satisfaction). Data will 
also be extracted at this time and directly entered into the computerized survey from 
patient clinic records (e.g., treatment regiment, CD4 count, viral load). Total duration of 
baseline interview is approximately 60 minutes. 
• 
6- and 12-month follow-up patient assessments (all patient participants). Patients at 
both clinics will complete a follow-up assessments at 4 time points, specifically 6 and 12-
months post-baseline. In a private space in the clinic or another agreed upon location, an 
interviewer will administer a structured questionnaire entered in CAPI software. Follow-up 
assessments may be administered via telephone for participants not returning to the clinic 
(incentives delivered elsewhere). At each time point, information will again be reviewed 
and extracted from clinic records and entered into CAPI software. Across all 2 
assessments, the total duration for survey participation is approximately 90 minutes (~45 
minutes per assessment). Patient participation will end after the completion of the 12-
month follow-up survey.  
Process Data 
Exit interviews with facilitators and key-stakeholders (post-intervention). Semi-structured 
qualitative interviews will be held with the 2 trainers (intervention facilitators), any provider not 
able to attend focus groups, as well as with 2-4 Mildmay leaders in charge of the integration of 
courses into Mildmay’s training programs to assess barriers and facilitators to the implementation 
and future adoption of the training and maintenance sessions.  See Table 3 for more detail on the 
CFIR constructs explored through these interviews. An audio-recorded, one-on-one semi-
structured interview will be conducted in a private setting by one of the PIs or research staff. After 
the completion of the key-informant interview, the key informants’ involvement in the study will 
end (total participation approximately 15-30 minutes). 
Exit focus groups with providers (post-intervention). We will conduct approximately 8 
additional exit focus groups with HIV providers participating in the training (6-8 provider per group) 
or until saturation is reached. We will purposively sample from each of the intervention health 
centers and include health workers and lay workers in separate groups. The purpose of these 
focus 
groups 
are 
to 
assess 
the 
perceived 
acceptability, 
feasibility, 
barriers 
to 

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implementation/adoption and other measures of implementation (see Table 1) among providers 
who participated in the training. The different constructs and their definition measured through 
focus groups mapped onto the CFIR framework are highlighted in Table 1. 
Data collection to assess intervention fidelity. To assess fidelity, each group training session 
will be observed by staff or Dr. Sileo with a checklist to assess 5 implementation fidelity 
dimensions: adherence, quality of delivery, program component differentiation, intervention 
exposure, participant responsiveness. We will observe ~5 randomly selected maintenance 
sessions (for rapid feedback). At the completion of the study, randomly selected maintenance 
transcripts (20%) will be qualitatively analyzed. 
 
Data management 
Qualitative data  
Audio recordings of all qualitative data will be transferred to a password protected computer. All 
focus group discussions, observations, key informant interviews, and qualitative exit interviews 
will be transcribed and translated into English and entered into a software analysis system 
(Atlas.ti). Electronic audio recordings of intervention sessions will be transcribed within 6 months 
of the session and the audio recordings will be destroyed once the information from the recordings 
is written down and double-checked for accuracy.   
Quantitative data  
Data for the baseline, 6- and 12-month follow-up questionnaires will be entered in real-time 
while the interviewers are conducting the interviewer-administered CAPI questionnaires (using 
Table 1. CFIR domains and constructs explored as barriers and facilitators to the implementation and 
adoption of the intervention  
CFIR Domain and constructs 
Sample* 
CFIR Domain: Intervention characteristics 
Intervention source: Perception of key stakeholders about whether the intervention 
was externally or internally developed 
Trainers, 
Stakeholders 
Complexity/barriers: Perceived difficulty of/barriers to implementation/application of 
content into clinical care 
Trainers, Providers 
Stakeholders   
Appropriateness: The perceived fit of the intervention for the setting and to improve 
care quality and patient outcomes 
Trainers, Providers 
Stakeholders   
CFIR Domain: Outer setting 
Patient needs: The extent to which patients’ gendered barriers and facilitators to care 
are accurately known and prioritized  
Trainers, Providers 
Stakeholders 
CFIR Domain: Inner setting 
Relative Priority: Perceived importance of implementation within the clinic and 
broader health system 
Trainers, Providers 
Stakeholders 
Culture: Organizational norms, values, and basic assumptions specific to: a) 
innovations in care and b) gender equity 
Trainers, Providers, 
Stakeholders 
CFIR Domain: Individual characteristics 
Knowledge and beliefs about the intervention: Attitudes towards and value placed on 
the intervention, including perceptions on acceptability (satisfaction with intervention) 
and feasibility (can intervention be carried out within clinic/broadly) 
Trainers, Providers, 
Stakeholders 
Self-efficacy: Beliefs in own ability to execute implementation goals (trainers) and 
training content (providers) 
Trainers, Providers  
Other personal attributes: Gender, age, and other traits 
Trainers, Providers 
*Data collection methods = Providers: focus group discussions, Trainers: in-depth interviews; Stakeholders: 
key informant interviews  

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KoboCollect software). Using the KoboCollect system also eliminates the possibility of any out 
of range responses and therefore, data cleaning is not necessary. Data collected using Kobo is 
easily exported into R, SPSS, and other statistical programs for analysis. A research assistant 
will extract data form medical charts and enter it into a database identified only by study ID 
number. Clinical record data will be double entered by the research assistant into this same 
data file upon receipt. The double entered data will be checked and any discrepancies will be 
corrected by double checking the clinic records, and by comparisons with the laboratory report. 
 
Data safety monitoring plan 
 
The proposed study will conform to rigorous monitoring procedures, standardized reporting of 
adverse events using Event Report Forms, and regular review of the study by the Principal 
Investigators, Drs. Wanyenze and Sileo. Dr. Sileo will have primary responsibility for the overall 
conduct of the study with oversight from Drs. Wanyenze and Kershaw, including the safety of 
human subjects. With the assistance of research staff, the PIs will ensure appropriate: (1) 
conduct of the informed consent process (e.g., that informed consent is obtained before 
proceeding with study procedures and properly stored), (2) enrollment of study subjects, (3) 
collection and analysis of data, (4) implementation of study procedures to ensure consistent 
monitoring of subjects for possible adverse events, (5) review of adverse events and reporting 
to the IRB, and (6) maintenance of the privacy and confidentiality of study subjects. 
 
Drs. Wanyenze and Sileo will be responsible for meeting with the research team on a regular 
basis (either in person or by conference call) to review the progress of the study and address 
any human subject issues that occur. These discussions may involve adverse event prevention 
measures, recruitment of appropriate study subjects, research staff training on protection of 
human subjects, as well as occurrence of adverse events, unexpected incidents, or protocol 
problems. Dr. Sileo will meet with the research assistants regularly to go over the progress of 
the study and communicate any issues or adverse events to the mentorship team. The research 
assistants will compile reports on this information and submit them to the Principal Investigator 
for review. Drs. Wanyenze and Sileo will present this information to Co-Investigators as needed 
to troubleshoot any issues and seek guidance in decision-making. 
 
Adverse events 
The study is of minimal risk and therefore no serious anticipated events are expected. Serious 
unanticipated events will be reported within 48 hours to the Makerere School of Public Health 
and University of Texas at San Antonio IRBs, the co-investigators listed on the protocol, and 
NIH. We expect the risk of adverse events resulting from participation in the intervention to be 
low. Further, we have developed procedures to reduce any adverse events and closely monitor 
participants in the provider training intervention. The implementation of these procedures will 
ensure any unanticipated adverse events are identified and addressed immediately (see 
“Protection of Human Subjects” section) for more details. 
 

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The Principal Investigators will conduct a review of all adverse events (serious and non-serious) 
every month during a scheduled meeting and keep a log of all events. They will evaluate the 
frequency and severity of the adverse event(s) and, in conjunction with the Makerere School of 
Public Health and University of Texas at San Antonio IRBs, determine if modifications to the 
protocol or consent forms are required. A report to the Makerere and University of Texas at San 
Antonio IRBs will be made when re-approval for the protocol is sought on a yearly basis, or 
more frequently if deemed necessary by the Principal Investigators and Co-Investigators based 
on the number and severity of adverse events. The summary will include the number of 
participants enrolled in the study and a summary of the adverse events to date (including 
relation to study and severity). 
 
The Principal Investigators, in conjunction with the Makerere School of Public Health and 
University of Texas at San Antonio IRBs, will be responsible for monitoring the data and 
conducting performance safety reviews at a minimum of every 3 months. The Principal 
Investigators will present this data to the full-team of Co-Investigators for guidance at bi-annual 
team meetings. The Principal Investigators, Makerere IRB, and the University of Texas at San 
Antonio IRB have the authority to stop or modify the study at any time. During the review 
process, the Principal Investigators will monitor and evaluate whether the study should continue 
unchanged, require modification, or close to enrollment. Discussions will be brought to the 
larger team of mentors as needed. 
Training of the RAs/Facilitators  
Training of research assistants  
To collect baseline and follow-up interview data for the intervention trial experienced research 
assistants/interviewers will be hired for the purposes of the study. These individuals will be trained 
in the study procedures by one or more of the investigators. The two-day training will cover the 
detailed standard-operating-procedures (SOP) as relevant to the role of research assistants. 
Procedures covered will include the schedule of data collection, procedures for contacting 
participants, storage of hard copies, storage and exporting of electronic data, and procedures 
related to obtaining informed consent. Safeguards to protect human subjects and reporting of 
adverse events will also be covered. Finally, the training will cover the objectives and content of 
the study and the tools. Mock interviews will be conducted by the research team to further get 
acquainted with the study tools during the training. The training will help the research assistants 
to master the data collection tools. Clinic staff will also be oriented to the study and the study 
procedures by the investigators.  
Training of intervention facilitators 
Group facilitators experienced in the delivery of behavioral interventions and Mildmay Expert 
Trainers who will deliver the intervention will undergo a 5-day curriculum-based training of the 
intervention content using role playing and simulated group discussions led by Dr. Sileo with 
oversight from Dr. Wanyenze. Training will emphasize the protection of human subjects and 
confidentiality, the role of gender norms in patient-provider relationships, managing group 
dynamics, facilitating transformative dialogues without creating conflict, and identifying and 
minimizing adverse outcomes. 

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Statistical Analysis Plan 
To evaluate the time by intervention effect on primary and secondary outcomes, we used 
Generalized Estimating Equations (GEE) in SPSS v. 28, which can account for dependency in 
the data related to the clinic clusters and repeated measures. First, we used GEE to examine 
baseline equivalence between treatment arms in both HIV care provider and client cohorts. We 
tested variables that differed at a level of p < 0.10 between treatment arms as covariates in the 
models testing intervention effect; only variables significant at p < 0.05 and/or making a 
difference in the intervention effect were maintained in the final models. We report the time by 
arm interaction. For all provider and client analyses, we tested the time by intervention by 
gender effect. For providers, we also tested the time by intervention by cadre effect, 
categorizing providers into certified health workers (licensed doctors, nurses, counselors) vs. lay 
health workers or non-specialized staff (e.g., peers). These interactions are only presented if 
they were statistically significant (p < 0.05). We report unstandardized betas (b) and standard 
errors (SE) for continuous outcomes and odds ratios (ORs) and adjusted odds ratios (AORs) 
and 95% confidence intervals (CIs) for binary outcomes.