Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,153
- 试验地点
- 2
- 主要终点
- Number of Participants Undergoing HIV Testing Within 12 Months
研究概览
简要总结
"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.
详细描述
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
- 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
- monitoring fidelity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The student is >16 years of age prior to the first session of SKILLZ-Girl or the student will turn 16 years of age before the last session of SKILLZ-Girl (ie prior to the event)
- •Is enrolled in one of the SKILLZ STUDY schools
- •Is able to converse in and comprehend either Nyanja, English and/or Bemba
- •The Parent/Guardian of the participant has consented for the participant to take part in the study
排除标准
- •The student has a mental disability that would interfere with their ability to give informed consent
结局指标
主要结局
Number of Participants Undergoing HIV Testing Within 12 Months
时间窗: 12 months
Number of participants, enrolled in the study, undergoing HIV testing (HIVST our Determine tests) over 1 year. Collected from facility testing registers and community testing registers.
Number of Participants Accessing Sexual and Reproductive Health Related Prevention Services Within 12 Months
时间窗: 12 months
Number of participants, enrolled in the study, accessing contraception, pre-exposure prophylaxis or post exposure prophylaxis over 1 year. Determined through the electronic medical record and clinic registers.
The Percentage of HIV Infected Participants Being Virally Suppressed at 12 Months
时间窗: 12 months
The percentage of participants, testing HIV positive, who have an undetectable viral load (as defined by the laboratory doing the test) after one year on treatment. Collected from routine laboratory data.
The Percentage of HIV Infected Participants Retained in Care at 6 Months
时间窗: 6 months
The percentage of participants, testing HIV positive, that have made their scheduled visit to the clinic within the first at 6 months of enrolment. (less than 7 days late), using the electronic medical record.
The Percentage of HIV Infected Participants Retained in Care at 12 Months
时间窗: 12 months
The percentage of participants, testing HIV positive, who attend their scheduled visits within the first 12 months of enrolment (less than seven days late). determined through the electronic medical record.
The Percentage of HIV Infected Participants Retained in Care at 3 Months
时间窗: 3 months
The percentage of participants, testing HIV positive, who are actively retained in care at 3 months ie are not more than 7 days late for a scheduled appointment. Determined using the electronic medical record.
次要结局
- Number of Participants Who Identified Barriers That Prevent Intervention Participation(Baseline through 12 months)
- Fidelity Monitoring or Adherence to the Program as Measured by the Number of Coaching Sessions Conducted Per Plan in the Enhanced Arm Only.(Baseline through 12 months)
- Total Short-term Costs for the Program Implementation Based on Net Costs for the Intervention.(Baseline through 12 months)
研究者
Carolyn Bolton
Principal Investigator
University of Alabama at Birmingham