Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial

Abstract

BackgroundAmong countries in sub-Saharan Africa, Zambia has one of the highest incidences of HIV. Adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability.ObjectiveThe goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia in order to connect AGYW with a source of regular care, which will in turn allow for sustainable, successful implementation of regular HIV testing and adherence to antiretroviral treatment.MethodsWe will adapt prior tools to create the SHIELD (Support for HIV Integrated Education, Linkages to Care, and Destigmatization) intervention to educate and empower Zambian AGYW of 10-24 years of age and their families and to create community-based youth clubs to foster peer support. We will also develop integrated wellness care clinics to offer a youth-friendly environment that provides tailored clinical services. We will perform formative research, including focus groups and in-depth interviews, among AGYW, caregivers, and stakeholders to help inform the development and tailoring of the interventions. A cluster-randomized controlled trial will be implemented in Lusaka, with six clinic catchment areas randomized into three groups: zones with integrated wellness care clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. We will assess HIV testing among the HIV-negative or unknown (HIV-/u) cohort, and retention in care along with viral load suppression will be evaluated in the HIV-positive (HIV+) cohort. We will use in-depth interviews and surveys to collect staff and stakeholder feedback after the trial. Cost-effectiveness of the interventions and return-on-investment impacts will be quantified using a microsimulation model.ResultsInterim results are expected in 2021, and the final results are expected in 2022. If this multilevel intervention is successful in establishing a comprehensive care continuum for HIV-affected AGYW, the Zambian Ministry of Health may advocate for expansion to additional settings to support national scale-up.ConclusionsThis integrated service delivery model can also be a platform to implement additional preventive services, so HIV-/u and HIV+ AGYW can receive comprehensive, integrated services.Trial RegistrationClinicalTrials.gov NCT03995953; https://clinicaltrials.gov/ct2/show/NCT03995953 International Registered Report Identifier (IRRID)PRR1-10.2196/15314

Self-management interventions for adolescents living with HIV: a systematic review

“… 4 times during pre-transfer (at 3, 6, 9, and 12 months); 3 times after transfer to adult clinic (at 15, 18 and 21 months) (total 36 months) Face-to-face HCW & Peer Sibinga (2018) [ 66 ] Mindfulness-based stress reduction (MBSR) Group 1) Material related to mindfulness, meditation, yoga, mind-body connection; 2) Experiential practice of mindful meditation; 3) Group discussions focused on problem-solving related to barriers to effective practice. 2-h sessions every week for 8 weeks and one 3-h session in week 9 Face-to-face Trained counsellor (MBSR instructor) Subramanian et al (2019) [ 67 ] Integrated Care Delivery of HIV Prevention and Treatment (SHIELD) Group SHIELD: Educational modules on HIV prevention and treatment, general wellness, SRH, communication skills etc. ; youth clubs.…”

Perspectives of Adolescent Girls and Young Women on Optimizing Youth-Friendly HIV and Sexual and Reproductive Health Care in Zambia

“…The HPV vaccination, which is generally not stigmatized as it is usually provided before sexual debut, can serve as an entry-point to provide expanded selection of services to AGYW ( 19 ). Our study highlights the willingness Zambian AGYW have in receiving the HPV vaccination with other HIV services along with the need for AGYW, especially among younger age groups, to have the educational and clinic resources needed for cervical cancer screening and prevention.…”

“…Our study highlights the willingness Zambian AGYW have in receiving the HPV vaccination with other HIV services along with the need for AGYW, especially among younger age groups, to have the educational and clinic resources needed for cervical cancer screening and prevention. These self-reported preferences were validated through a pilot test exercise conducted by the study team in which 25 AGYW chose to receive the HPV vaccination and provided positive feedback on the integrated clinic services ( 19 ). Our study found that the lack of knowledge on age eligibility by some AGYW suggests a need to offer these services in AGYW-specific settings.…”

“…AGYW are in a period of transition as they age through adolescence and approach adulthood ( 18 ). AGYW affected by HIV not only need HIV-related services but also access to contraception, treatment for sexually transmitted infections, ability to seek preventive care such as Human Papilloma Virus (HPV) vaccination to protect against cervical cancer, and options to receive confidential counseling services ( 14 , 18 , 19 ).…”

A Cascade of Interventions to Promote Adherence to Antiretroviral Therapy in African Countries

“…In South Africa, the Lotto to Link trial is using a conditional lottery incentive to engage men in HIV testing and treatment and achieve viral suppression [49] Similarly, the Zwakala Ndoda trial combines male-focused HIV testing, personalised linkage to care, case management and flexible clinic hours to encourage linkage and engagement in care for men [50]. In Zambia, the SHIELD trial aims to demonstrate the use of peer support within communitybased youth clubs and tailored clinical services for young women and adolescent girls [51]. The VIBRA trial in Lesotho will build on previous evidence from Labhardt et al [15 •• ] and hopes to demonstrate the effectiveness of taskshifting same-day ART and drug refill by village health workers, with the option of adherence reminders and lab result delivery by SMS [52].…”