Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia
Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia
The study team will test a multilevel package of interventions to connect adolescent girls
 and young women (AGYW) with a source of regular care to provide a sustainable platform for
 successful implementation of regular human immunodeficiency virus (HIV) testing and support
 for linkage to care, retention in care, and adherence to antiviral treatment. Interventions
 will include integrated wellness care (IWC) clinics and the SHIELD intervention (Support for
 HIV Integrated Education, Linkages to care, and Destigmatization) to educate and empower AGYW
 and their families, and to create community-based youth clubs to foster peer support. A
 cluster randomized controlled trial will be implemented with 6 geographic regions randomized
 into 3 groups: zones with IWC clinics and SHIELD intervention, zones with only SHIELD
 intervention, and control zones with no intervention. HIV testing will be assessed among the
 SHIELD only HIV negative or unknown (HIV-/u) cohort and retention in care along with viral
 load suppression will be primarily assessed in the IWC clinics and SHIELD HIV positive (HIV+)
 cohort. In-depth interviews and surveys will be used to gather staff and stakeholder feedback
 following the trial. Cost-effectiveness of the interventions and budgetary impacts will be
 assessed through using a cost assessment tool.
The overall goal of this study is to develop and test a multilevel package of interventions
 to connect adolescent girls and young women (AGYW) of ages 10-24 in Zambia with a source of
 regular care to provide a sustainable platform for successful implementation of regular HIV
 testing and support for linkage to care, retention in care, and adherence to antiviral
 treatment. To meet the overall goal, the study team will adapt prior tools to create
 integrated wellness care (IWC) clinics and the SHIELD intervention (Support for HIV
 Integrated Education, Linkages to care, and Destigmatization) to educate and empower AGYW and
 their families, and to create community-based youth clubs to foster peer support. The
 researchers will test the hypothesis that the combination of IWC clinics, age-appropriate
 SHIELD interventions for AGYW and their families, and peer support will increase HIV testing,
 retention in care, and viral load suppression compared to the current standard-of-care
 clinical services with or without the SHIELD intervention.

 Interventions

 The SHIELD intervention is based on social cognitive theory, which posits that positive
 behavior change requires knowledge and skills to increase behavioral capability, development
 of self-efficacy to increase the belief that one can achieve the desired outcomes, and social
 support to provide positive reinforcement and develop positive outcomes expectations. The
 researchers will develop a three-session, six-module program for AGYW that increases
 knowledge, skills, and self-efficacy to engage along the HIV prevention and care continuum,
 and a two-session, four-module program for family members to increase social support.
 Intervention content for both AGYW and families will be tailored for five distinct groups to
 reflect development stage and AGYW's HIV status. Modules will be adapted from existing
 evidence-based interventions, such as Stepping Stones and Families Matter! based on community
 advisory board (CAB) and youth advisory board (YAB) input and formative research with AGYW,
 caregivers, and community leaders. Modules will address HIV prevention and treatment, general
 wellness and sexual and reproductive health (SRH), approaches to combat stigma and
 discrimination, and skills for better communication, and include new content on health
 service availability and access to increase self-efficacy in seeking health care services. In
 addition to the education modules, we will establish youth clubs for the five distinct groups
 by adapting those created for a prior initiative. Youth clubs will be facilitated by peer
 navigators, who will be AGYW aged 16 to 24 years, and trained in participant confidentiality,
 AGYW rights, basic counseling skills, overview of SRH and HIV continuum of care, processes of
 referral and linkages for health services, recruitment strategies, and study aims.

 Formative Research

 To inform the adaptation of existing materials and new content for the SHIELD intervention,
 the study team will conduct formative research with AGYW, their parents, and community
 leaders to explore their perceptions of HIV, stigma, and social support. The study team will
 conduct in-depth interviews (IDI) and focus group discussions (FGD) with AGYWs to explore
 their knowledge about HIV and the perceived importance of prevention, testing, and
 antiretroviral therapy (ART) adherence (as applicable). The study team will examine barriers
 and facilitators to HIV care or prevention, with a focus on the types of stigma experienced
 and social support. The study team will also explore AGYW's knowledge of availability of
 health services and their preferences for service delivery, which will also inform the
 discrete choice experiment (DCE) attributes and levels. The researchers will conduct focus
 group discussions (FGDs) with parents and other caregivers of HIV-uninfected AGYW, and FGDs
 with caregivers of HIV-infected AGYW, to discuss participant's views about their daughters'
 access to SRH services and HIV care, the stigma that AGYW and their families experience when
 AGYW use these services, and barriers to and facilitators of family support for AGYW's access
 to care. Finally, the research team will conduct IDIs with community stakeholders such as
 health care providers, church leaders, and teachers to explore their views on how best to
 reduce stigma within their communities.

 Findings from the formative research will help to identify content that should be adapted or
 added to the SHIELD intervention to address locally relevant barriers to HIV prevention,
 testing, treatment, and care. The researchers will review the findings and develop draft
 training modules and the youth club protocols. The modules will be tested with participants
 from each AGYW cohort, families of HIV-uninfected AGYW, and families of HIV-infected AGYW to
 fine-tune content and delivery. The data from this pre-testing phase will be used to make
 final revisions to the intervention content, manual, and training materials in preparation
 for the trial implementation.

 IWC Clinic Intervention

 IWC clinics will be created within health facilities where AGYWs can receive sexual and
 reproductive health services, including HIV testing and treatment, family planning, sexually
 transmitted disease screening and treatment, and human papilloma virus (HPV) vaccination. IWC
 clinics will be established in existing government health facilities and will follow the
 model of the cervical cancer screening clinics. SOPs will be developed to include HIV, HPV
 vaccination, and SRH clinical guidelines specific to the AGYW, care pathways mapped out for
 common problems or conditions, procedures to maintain patient privacy, quality assurance
 checklists, and details on documentation and data capture (pre-programed computer tablets
 will be used to enter study data). The researchers will also map out the physical structure
 and layout of the room for the IWC to ensure ergonomics in patient care processes and offer
 privacy for physical exams. The study team will explore the best options for placement of the
 IWC clinic within the health facilities with the use of at least two rooms: one devoted to
 the intake process and another for medical examinations. To accommodate AGYW who are
 generally not available to attend clinics during work or school hours, the IWC operational
 hours will include early morning, late evening, and weekend hours. Given this proposed
 schedule, it may be possible to share space with the cervical cancer screening clinic, which
 generally has at least two dedicated rooms and operates on a more conventional workday
 schedule.

 IWC clinic and health center staff will be trained to ensure that staff offer holistic HIV
 and SRH services, including family planning, sexually transmitted infection diagnosis and
 treatment, and condom promotion, in a nonjudgmental and friendly manner. This training will
 include learning the standard operating procedures (SOPs), gaining hands-on experience by
 shadowing nurses based at the same facility to understand clinic procedures, and stigma
 training that can give staff the skills to create a stigma-free health facility.

 Discrete Choice Experiment (DCE)

 A DCE along with a supplemental survey will be administered to systematically evaluate
 preferences for HIV clinical care services. AGYW will be asked to choose among constructed
 scenarios with varying combinations of key attributes relevant to HIV and other clinical care
 services (for example, service availability, wait time, operating hours, provider type, and
 protection of privacy); choosing not to attend the clinic will also be an option. To permit
 use in a low-literacy environment and to ensure an AGYW-tailored approach, the attributes and
 levels will be converted into graphics. The DCE selection will generate 200 possible
 scenarios based on attributes and levels. To select a fractional set of scenarios (target of
 128 profiles), the study team will employ a randomized design process that ensures that
 respondents see well-balanced and near-orthogonal fractions of the full-choice design (eight
 choice decisions per respondent).

 The study team plans to perform sub-analyses by age group and HIV status to assess
 differences by developmental stage and have ensured that the sample size of 1,000 HIV-/u
 (approximately 330 in three groups) and 800 HIV+ (400 in 2 groups) will be adequate to
 perform the planned analysis. In addition to the choice tasks, the study team will administer
 a supplemental survey to obtain demographics, socioeconomic status, reproductive history,
 access to care, attitudes towards using formal medical care, and stigma associated with HIV
 diagnosis. The findings from the DCE will be supplemented with information gained from other
 qualitative (interviews and focus groups) and quantitative (patient supplemental survey) data
 collection to ensure a comprehensive and context-based interpretation of the results. These
 findings will be used to tailor the services, hours of operation, and overall structure of
 the IWC clinic-based intervention.

 The study team will conduct pilot testing to assess the SOPs in practice, and review the
 patient flow and interaction with the IWC staff. The study team will recruit a sample of AGYW
 from the clinic catchment area to receive services at one of the IWC clinics. Each AGYW will
 be offered HPV vaccination, counseling for HIV testing, and SRH services; the AGYW will also
 be encouraged to discuss additional health care needs. Those who choose to receive HPV
 vaccination will be given a follow-up appointment so the study team can also monitor the
 process of providing the second vaccine dose (second dose will be provided at 6 weeks or 6
 months, depending on the 2- or 3-dose schedule; AGYW will be followed to ensure they complete
 the required doses, but only the 6-week dosage will be included in the pilot study). The
 study team will use time and motion methodology to monitor the AGYW interaction and
 activities at the clinic from initial check-in to the end of the visit; the data will be used
 to assess patient wait times and disruptions in the patient flow. This information, along
 with the feedback from the AGYW (who will undergo a short interview at the end of the first
 visit) and the IWC nurse and peer navigator team (interviewed at the completion of all pilot
 test visits), will help identify any changes that need to be incorporated to improve the care
 processes. The SOPs will be revised by incorporating lessons from the pilot testing, and the
 nurses will receive additional training when necessary.

 Cohort recruitment and sampling frame

 Identify AGYW to establish a sampling frame. In collaboration with the Ministry of Health
 (MOH), we will identify six health centers or clinics that provide HIV services and cervical
 cancer screening in Lusaka district. The study team will identify AGYW for inclusion in the
 catchment areas of these clinics, zones immediately surrounding the clinics. To avoid
 potential cross-contamination, the study team will select clinic zones that are not
 contiguous. The AGYW recruited using this approach will serve as the cohort for conducting
 the DCE and the sampling frame for random selection to participate in the cluster randomized
 trial. The sample sizes required for these follow-on assessments were taken into account in
 determining the size of the initial HIV-/u and HIV+ cohorts, and the feasibility of
 recruiting the targeted number of AGYW is based on prior and ongoing studies conducted by the
 grant team. The systematic approach to establishing the sampling frame will provide discrete,
 non-duplicated individuals (the participant list will be updated daily); reduce selection
 bias by ensuring a more representative sampling for the cluster randomized trial; and also,
 if necessary, allow for adjustments in the random selection process so AGYW cohorts are
 similar.

 To identify the HIV-/u cohort, the study team will map out each neighborhood and households
 within the clinic catchment area with the assistance of the local Neighborhood Health
 Committees, the community liaisons attached to the clinics, and the outreach staff from the
 cervical cancer program. Peer Navigators (PNs) will visit each household, beginning with
 residential areas closest to the clinics, to identify eligible AGYW and recruit them to
 participate in the study. Participants will be notified of their rights, that questions
 regarding HIV status will be discussed, and that their refusal to participate will not affect
 their access to health care or other services. All AGYW 18 years of age and older will
 provide written informed consent in their preferred language, and parental consent will be
 obtained for participants under 18 years of age followed by assent from these minors. The
 study team will include one AGYW per household and enroll AGYW on a continual basis until
 desired enrollment targets are reached. Participants in the HIV-/u cohort must (a) be female;
 (b) be 10 to 20 years of age; and (c) self-report their HIV status as negative or unknown (no
 HIV testing within the past 6 months).

 The study team has selected the 10 to 20 age group because this is the highest-priority
 cohort and because prevention interventions are best targeted to this age group, as high-risk
 young women older than 20 years are likely to be HIV positive already. Additional inclusion
 criteria include (d) is not pregnant, does not suspect she is pregnant, and does not express
 desire to become pregnant over the next 18 months; (e) is willing to sign a release for
 medical records (to obtain clinic data on service use); (f) plans to reside in the current
 location for the next 18 months; and (g) has not been part of the other planned formative
 research activities. The study team is excluding pregnant AGYW because their motivations and
 health-seeking behaviors are likely to change during pregnancy, they require specialized
 antenatal care, and they are not eligible for the HPV vaccine that will be offered to the IWC
 clinic participants. All pregnant AGYW identified during the study will be offered assistance
 to obtain care at appropriate antenatal clinics. The study team will recruit 160 to 170
 adolescent girls from each clinic catchment area, with equal numbers in 10 to 12, 13 to 15,
 and 16 to 20 age ranges, for a total of 1,000 girls.

 For the HIV+ cohort, to maintain confidentially, the study team will request that health
 providers and community outreach staff at target clinics, along with staff from
 community-based testing centers, approach eligible HIV+ AGYW who reside in the clinic
 catchment area (identified through patient record review). The use of community outreach
 staff will allow targeting AGYW who are HIV+ but not receiving treatment. Those who
 voluntarily indicate that they are HIV positive during recruitment of the HIV-/u cohort will
 also be given the opportunity to enroll in the HIV+ cohort when eligible. Participants who
 are female, 16 to 24 years of age, and diagnosed with HIV within the past 3 years (to target
 relatively recently diagnosed AGYW at the time of recruitment) will be eligible for inclusion
 in the study. The study team will continue enrollment until the enrollment target is reached.
 Those who receive a new HIV+ diagnosis during the 3-month recruitment time frame will also be
 included. In Zambia, sexual acts with adolescents younger than 16 years, even if consensual,
 are considered criminal. Given the possible negative repercussions that AGYW may experience
 should they be reported and our desire to maintain a trusting relationship with the
 communities that are served, the study team will not recruit adolescent girls aged 15 years
 and younger for the HIV+ cohort. The study team will enroll a total of 800 HIV+ AGYW,
 targeting a similar number (130 to 140) from each clinic zone with equal representation among
 those 16 to 20 and 21 to 24 years of age. The additional inclusion criteria will also be
 applied to the HIV+ cohort.

 Data Collection Procedures

 The study team will collect data from AGYW, their caregiver (identified by AGYW), clinical
 staff, and PNs electronically using computer tablets with pre-loaded software and
 instruments. Instruments will be available in English, Bemba, Nyanja, and Tonga as needed. To
 facilitate use by younger girls who may not be fully literate, the study team will include a
 voice-enabled component, which will allow AGYW to listen and respond to questions. In
 addition, AGYW can use the tablet, along with headphones, to self-administer the instrument
 to answer sensitive questions related to sexual risk and HIV status. All instruments for data
 collection will be created (with adjustments as needed for each AGYW age group) and
 pretested, using the same set of AGYW and caregivers selected for pretesting the SHIELD
 intervention. The study team will also identify five clinical staff and five PNs who will not
 be participating in the study to pretest provider specific data collection instruments. To
 ensure the highest level of fidelity and adherence to the protocol, all data collectors will
 receive in-depth training and monitoring. Additionally, the study team will be abstracting
 required data elements through clinic audit from the six clinic sites included in the study;
 the study team have the Zambian Ministry of Health's (MOH's) support to interact with clinic
 personnel and conduct record abstraction. The study team will perform pilot data abstraction
 to review quality of data at each site and conduct a series of trainings for clinic staff to
 address problems identified and implement procedures to ensure high-quality data are
 available for the study.
Inclusion Criteria:

 HIV negative or unknown cohort

 -  Female

 -  10 to 20 years of age

 -  self-report HIV status as negative or unknown (no HIV testing within the past 6 months

 -  not pregnant, does not suspect pregnancy, and does not express a desire to become
 pregnant over the next 18 months

 -  is willing to sign a release for medical records (to obtain clinic data on service
 use)

 -  plans to reside in the current location for the next 18 months

 -  has not been part of the other planned formative research activities

 HIV positive cohort

 -  Female

 -  16 to 24 years of age

 -  diagnosed with HIV within the past 3 years or newly diagnosed at the time of the study

 -  not pregnant, does not suspect pregnancy, and does not express a desire to become
 pregnant over the next 18 months

 -  is willing to sign a release for medical records (to obtain clinic data on service
 use)

 -  plans to reside in the current location for the next 18 months

 -  has not been part of the other planned formative research activities

 Exclusion Criteria:

 -  pregnant