Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ

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Research Aims & Objectives: Aim 1: Assess the impact of SKILLZ over two years on: (i) (a) HIV testing and (b) SRH-related prevention services uptake among adolescent girls aged 16-19 in up to 9 intervention schools in Lusaka, Zambia (with enhanced HIVST, PrEP, and contraceptive method offerings) com...

Research Aims & Objectives: Aim 1: Assess the impact of SKILLZ over two years on: (i) (a) HIV testing and (b) SRH-related prevention services uptake among adolescent girls aged 16-19 in up to 9 intervention schools in Lusaka, Zambia (with enhanced HIVST, PrEP, and contraceptive method offerings) compared to up to 9 control schools using a quasi-experimental difference-in-difference approach; and (ii) linkage to care and treatment, and viral load suppression and retention at 6, 12, and 24 months 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 and enrolled in SKILLZ-Plus. This will be achieved by i) using a quasi-experimental difference-in-difference approach that compares girls aged 16 and over in 9 SKILLZ control schools compared to 9 schools where enhanced 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: (i) 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 (ii) 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. Study Design This is a mixed-methods evaluation of the SKILLZ intervention in Lusaka, Zambia using the following approaches: (1)A quasi-experimental cohort of school-aged 16-year old and over females to be followed for a two-year period will be evaluated with a difference-in-difference (DID) approach to estimate HIV testing uptake and sexual/reproductive health services use. (2) A process evaluation to better understand the casual pathways and effect mediators and moderators using mixed methods approaches, including supplemental qualitative data collection; (3) Fidelity monitoring 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; and (4) Economic evaluation to estimate the short- and long-term cost-effectiveness and return on investment of SKILLZ for improving health outcomes for adolescent girls. Selection of participants, sampling methods and sample size The study will take place across all the highly densely populated areas of Lusaka where CIDRZ supports government MoH clinics with ARV services, electronic data management, and youth-friendly trained clinical personnel, and where GRS has been implementing their basic curriculum and events. All schools selected will be secular government schools. The study will recruit all girls in Grade 10 who are at least 16 years old at the start of the intervention period (i.e., the commencement of SKLLZ-Girl). Of the 30,000 youth in Lusaka that have benefitted from GRS services to date, GRS has seen HIV testing uptake of 62% as compared to a baseline of 13% (internal program data). The study sample size is powered for the primary endpoints in Aim 1ii to account for attrition anticipated along the cascade (see below). For HIV testing, all eligible girls (estimated to be an average of 100 girls per school in up to 18 schools) is large enough to detect a significant difference in testing uptake if defining statistical significance at p-value=0.05, power=0.2, ICC=0.1, and an expected testing uptake of 60% (control) and 80% (intervention). Study sites The study will be conducted in up to 18 (2 pilot + 16 for full implementation) schools from the Urban District of Lusaka to receive the SKILLZ-Girl curriculum. Of the total (up to 18), half will be randomly allocated to host the standard SKILLZ-Girl curriculum, and the remaining half (e.g., up to eight) will be randomized to the enhanced SKILLZ-Club. Those schools randomized to standard SKILLZ Girl curriculum will only have access to SOC clubs. Those schools selected for enhanced SKILLS Girl curriculum will offer SKILLZ Club. For the small minority of girls found to be HIV-infected across all study schools, linkage to care and on treatment, VLS, and retention in care will be evaluated for a period of two years. These girls will be encouraged to continue in to the HIV positive-specific SKILLZ-Plus facility-based curriculum. The impact of SKILLZ-Plus on linkage to care and treatment, retention and viral load at 6, 12, and 24 months after diagnosis (or since participant is identified by GRS as HIV+) will be quantitatively measured using SmartCare data and compared to an existing matched cohort. Data collection plan and tools SmartCare electronic data: All antiretroviral therapy services offered to participants who are in the study are captured in 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. 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 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 after the events (this will include accessing PrEP, STI testing and contraceptive methods). 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 all to collect information on school characteristics, sexual behavior, 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 3,200 girls will respond to a self-administered survey using REDCap software upon informed consent. The survey will be available in English, Nyanja and Bemba Survey post-SKILLZ-Girl event, 3-, 12-, and 24 months: All girls (regardless of HIV status) will complete a REDCap survey to collect information on sexual behavior, 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 3 months after the SKILLZ-Girl community soccer event; coaches will help them navigate the survey. 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. Qualitative methods: Through a phenomenological and narrative study approach, the study aims to understand factors involved in decision-making for uptake by learning from girls about how psychological, social and structural factors affected their health decisions also including personal beliefs, perceptions and motives. Additionally, the study will document individual stories (narrative approach) regarding how HIV infected girls experience the mediating factors (such as stigma, disclosure, social support and trust in the health facility) and how they affect their adherence to care Extraction of GRS programmatic data: Quantitative measurements coming from programmatic GRS data (e.g., frequency and attendance at SKILLZ-Plus meetings, frequency of home visits) will be collated from reports, supplemented with interviews of implementing staff (e.g., program managers and coordinators, coaches) to track key process indicators. 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.

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