Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04429061 |
| Other study ID # |
IRB-300002251 |
| Secondary ID |
R01MH116789 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2020 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
"SKILLZ," is a mixed methods evaluation of the Grassroots Soccer (GRS) SKILLZ Package based
in Lusaka, Zambia. The package is made up of three football-based programs: (1) SKILLZ-Girl -
implemented in schools as part of a 10-week program culminating in a tournament event; (2)
SKILLZ-Club - implemented as an ongoing extra-curricular activity after the completion of
SKILLZ-Girl; (3) SKILLZ-Plus - a clinic based football group targeted at girls that are
HIV-positive.
The programs work together to build a continued support system which encourages uptake of
Sexual Reproductive Health (SRH) and HIV services, while facilitating ART adherence (for
HV-positive participants) and continued engagement with health services over the long-term
(whether to contraceptive methods, HIV prevention services, HIV repeat testing, and/or HIV
treatment and care).
The study team has developed an enhanced SKILLZ-Girl offering, which will include a
comprehensive module on HIVST, contraceptives and PrEP, access to a nurse during the
implementation of sessions and the additional offering of HIVST and contraceptive services at
the event along with ongoing engagement through the SKILLZ-Club program (Enhanced Arm) , The
central hypothesis is that this enhanced curriculum will increase HIV testing and
contraceptive uptake compared to the standard SKILLZ curriculum & standard event (SOC Arm).
The investigators further hypothesize that the intervention in the enhanced arm will
positively and directly affect a number of mediating factors including attendance at soccer
events where community-based SRH services are offered, SRH knowledge, empowerment,
self-confidence, and perceptions of gender balance, and (reduced) stigma.
For girls found to be HIV-positive, the follow-on SKILLZ intervention (SKILLZ-Plus) has been
designed to facilitate linkage to HIV care and treatment, reduce HIV-related stigma, increase
disclosure to family and partners, increase feelings of social support, empowerment,
self-efficacy, and ultimately adherence to ARVs, viral load suppression (VLS) and retention
in HIV care and treatment.
This study will be conducted in up to 32 secondary schools that GRS currently serves in the
Lusaka Urban District.
Description:
Research aim(s)/General Objective and Specific Objectives Aim 1: (a) Assess the impact of
SKILLZ over two years on HIV testing and (b) SRH-related prevention services uptake among
adolescent girls aged 16-19 in up to 23 intervention schools (with enhanced HIVST, PrEP, and
contraceptive method offerings) compared to up to 23 control schools using a
quasi-experimental difference-in-difference approach; and
Aim 1: (b) Describe linkage to care and treatment, and viral load suppression and retention
at 6, 12, and 18 months for girls who are identified to be HIV+ during the study, using
qualitative, programmatic, and administrative data.
This will be achieved by i) using a quasi-experimental difference-in-difference approach that
compares girls aged 16 and over in approximately 23 SKILLZ control schools compared to
approximately 23 schools where SKILLZ will be delivered with the enhanced HIVST and a variety
of contraceptive method offerings; and ii) through a cohort model using pre-existing
SmartCare data on HIV+ individuals in care to match to adolescent girls aged 16 and over from
the same district (Lusaka) who are identified to be HIV+ at any time during SKILLZ-Girl or
SKILLZ-Club participation.
Aim 2: Examine how the intervention works including lessons learned for future implementation
by
1. conducting a process evaluation to identify mediators, predictors, and barriers to
uptake of the SKILLZ-Girl, Club, and Plus curricula both quantitatively through
mediation and moderation analyses and qualitatively through a sequential explanatory
approach using focus groups discussions, interviews and observation with coaches and
girls; and by
2. monitoring fidelity
Aim 3: Estimate the short- and long-term cost-effectiveness and return on investment of the
SKILLZ Girl, Club, and Plus curricula for improving health outcomes for adolescent girls.
This is a mixed-methods evaluation of the SKILLZ intervention using the following approaches:
A quasi-experimental cohort of school-aged 16-year-old and over females to be followed for a
period of 18 month will be evaluated with a difference-in-difference (DID) approach to
estimate HIV testing uptake and sexual/reproductive health services use. Primary and
secondary outcomes will be measured at several timepoints longitudinally across up to 23
schools offering the SKILLZ-Girl and SKILLZ-Clubs program and up to 23 schools offering the
"standard of care" (SOC) and SOC Clubs. Recruitment is anticipated to take 6 months on a
rolling basis. The order in which schools will be selected will be random. Participants will
be clustered at the school-level; a random sample of girls will be enrolled from each
participating school, aged 16-years at the commencement of SKILLZ-Girl and who are in a grade
where GRS is offering the SKILLZ-Girl curriculum All enrolled girls will be followed over the
18 months' time period to assess SRH service uptake, including HIV testing. It is estimated
that the majority (~98%) of girls testing for HIV will likely be HIV-negative, based on
estimates from programmatic GRS data. While HIV-positive girls will continue to participate
in the school-based SKILLZ-Girl and Clubs activities and followed for SRH use, they will also
be offered contemporaneous enrolment into SKILLZ-Plus upon infection; retention in care and
Viral Load Suppression (VLS) at 6, 12, and 18 months will be measured for this subset.
Process evaluation: A process evaluation will be conducted to better understand the casual
pathways and effect mediators and moderators using mixed methods approaches, including
supplemental qualitative data collection. To investigate reasons why the program components
(SKILLZ-Girl, Club & Plus) might fail or succeed in different schools or communities and
assess intervention effect mediators and moderators for HIV testing and contraceptive use
uptake we will use a mixed methods approach involving: (1) quantitative analyses of baseline
survey data for testing how variables can moderate the observed impact of the intervention,
and (2) qualitative data collected from a subset of SKILLZ participants in the evaluation
cohort and their coaches to further understand potential mediating pathways.
Fidelity monitoring: The study includes measures to monitor fidelity of the intervention
implementation, including receptivity to and understanding of the intervention amongst
participants, the perceived appropriateness and relevancy of the intervention for adolescent
girls in school, and the extent to which the intervention was delivered per protocol in
different communities and schools.
Economic evaluation: Time permitting (given the uncertainty of delays due to COVID), the
study will estimate the short- and long-term cost-effectiveness and return on investment of
SKILLZ for improving health outcomes for adolescent girls.
Data collection plan and tools SmartCare electronic data: All antiretroviral therapy services
offered as part of the study will be captured in the National EMR, SmartCare, which permits
measuring of utilization and clinical outcomes (i.e., Linkage to Care, VLS) at soccer events,
mobile clinics, and public clinics in Lusaka. VLS is defined as below detection, i.e., less
than 50 copies/ml. Retention in care will also be measured using SmartCare data on pharmacy
visits and defined as accessing pharmacy within a 90-day window of visits. Consent will be
requested from all participants as part of the consent process to access their SmartCare
records.
Youth-Friendly services electronic data: Depending on the location of the school, the girl's
residential address and/or her own personal preferences, participants will be referred to
either the PEPFAR Funded DREAMS houses or the M.A.C. funded youth-friendly spaces based in
local MOH clinics in order to access ongoing SRH services not provided by the coaches in
their CBD role (this will include accessing PrEP, STI testing and long-term contraceptive
methods). All interactions with the DREAMS houses or M.A.C centres (including meeting with
counsellors, referral and uptake of services) are captured in their respective electronic
databases. Consent will be requested from all participants as part of the consent process to
allow researchers to access either DREAMS or M.A.C data should they chose to access either of
these services.
Survey at baseline: A baseline survey will be administered to approximately 50 girls per
school randomly selected to participate in the evaluation to collect information on school
characteristics, sexual behaviour, age, HIV knowledge, maternal education, baseline HIV
status, and sexual/reproductive health uptake and retention. These variables will be used as
covariates and moderators for service uptake and retention. The target sample of
approximately 1380 girls will respond to a survey self-administered using ODk software upon
informed consent. The survey will be available in English, Nyanja and Bemba. Coaches and
study staff will on site be help girls navigate the survey. If during baseline, it appears
that there has been sufficient time to measure change, or the full SKILLZ-Girl curriculum was
not administered, the baseline survey may be re-administered to assist with validation of
responses (as opposed to implementing the follow-up survey provided below).
Survey post-SKILLZ-Girl event, 6-, 12-, and 18 months: A total of approximately 30 girls per
school (regardless of HIV status) will respond to a ODK survey to collect information on
sexual behaviour, HIV knowledge, maternal education, sexual/reproductive health uptake and
retention. Post-SKILLZ-Girl survey data will be used to assess the effect of SKILLS Girl and
SKILLZ-Club on the outcomes of interest. In schools selected to offer SKILLZ-Club, surveys
will be conducted during club attendance approximately 6 months after the SKILLZ-Girl
community soccer event. Surveys will be completed individually by the participant on a secure
tablet physically or via phone. Study staff will be available to assist participants to
navigate the survey if they request assistance. If a participant has opted to not attend the
clubs or has since left or changed schools, the coaches and study staff will attempt to trace
participants in the community in order to complete the follow-up survey.
Where a participant is contacted for follow-up and it is discovered that she has left Lusaka,
Chilanga, Chongwe and Kafue districts and it is not possible for study staff to arrange a
visit to meet with her, a personalized survey link will be sent to her via email or WhatsApp
(based on the participant's preference). She will then be invited to complete and submit the
survey online. Alternatively, if the participant prefers study staff will complete the survey
with the participant over the phone and enter their responses directly into ODK.
In the schools selected not to offer SKILLZ-Club, GRS will arrange for a 2-hour meeting
session with all participants still enrolled at that school, where all participants will
complete the surveys. If a participant opts to not attend the meeting or has since left or
changed schools, the coaches and study staff will attempt to trace participants in the
community in order to complete the follow-up survey.
Data management and storage
Quantitative:
Individual-level data will be collected on clinical, laboratory, and demographic
characteristics, including retention in care and VLS at 6, 12 and 24 months. Using case
reporting forms (CRFs), the team will collect study-specific data, including information
obtained directly from participants, routine programmatic data from GRS and abstract routine
clinical data from paper-based medical records, the SmartCare Electronic Management Records
(EMR), CIDRZ Laboratory Information Management System (LIMS) and DREAMS electronic management
system. Routinely collected individual-level clinical data are first written onto forms in
the paper medical record and then entered into the SmartCare EMR. SmartCare serves as a
repository of clinical data for HIV-infected individuals and includes such data fields as:
ART initiation date, ART regimen, visit dates, and laboratory data.
GRS will collect programmatic data through a combination of paper and electronic data entry
via tablets, with all data stored securely in RedCap. Where paper files are used for
programmatic management, data will be manually entered by study staff directly into the
RedCap database. De-identified data will made available to GRS co-investigators to enable
review of key fidelity and quality indicators in order to monitor implementation in real
time.
All paper study files will be stored in secured, locked cabinets located in locked rooms
available to study staff only. A secure server will be used to store encrypted study data,
including the study database. All personal identifiers will be removed prior to generating
the analytical dataset.
Qualitative:
All data will be obtained using digital audio recorders. Recorded data will be transferred on
to a lockable computer kept by the co-principal investigator leading the qualitative
research. Transcripts will go through a QA/QC process where researchers will cross check
randomly selected transcribed verbatim with the recordings.
Data analysis plan The primary outcome is the probability of testing for HIV at any time
during the period when SKILLZ is delivered through to 24 months after the final soccer event.
The primary analysis for Aim 1 will follow a difference-in-difference (DID) effect between
study arms. The outcome of interest will be regressed on an indicator of study arm assignment
interacted with a dichotomous variable POST which indicates the outcome after the
intervention is implemented; this differentiates baseline and end-line for each study arm,
controls for any time dependent variables that might confound the effect, as well as any
time-invariant observed or unobserved confounders that might differ between study arm
schools. Clustering by school will be accounted for by a generalized estimating equation
approach. Intention-to-treat (ITT) will be evaluated by including all girls in the evaluation
cohort assigned to each arm rather than all girls who actually participated in SKILLZ.
