High-Yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS Study): Implementation Science Protocol for a Priority Population

Abstract

BackgroundSub-Saharan Africa is the region with the highest HIV burden. Adolescent girls and young women (AGYW) in the age range of 15 to 24 years are twice as likely as their male peers to be infected, making females in sub-Saharan Africa the most at-risk group for HIV infection. It is therefore critical to prioritize access to HIV testing, prevention, and treatment for this vulnerable population.ObjectiveUsing an implementation science framework, the purpose of this research protocol was to describe the approaches we propose to optimize engagement of AGYW in both the HIV prevention and care continuum and to determine the recruitment and testing strategies that identify the highest proportion of previously undiagnosed HIV infections.MethodsWe will compare two seek recruitment strategies, three test strategies, and pilot adaptive linkage to care interventions (sequential multiple assignment randomized trial [SMART] design) among AGYW in the age range of 15 to 24 years in Homa Bay County, western Kenya. AGYW will be recruited in the home or community-based setting and offered three testing options: oral fluid HIV self-testing, staff-aided rapid HIV testing, or referral to a health care facility for standard HIV testing services. Newly diagnosed AGYW with HIV will be enrolled in the SMART trial pilot to determine the most effective way to support initial linkage to care after a positive diagnosis. They will be randomized to standard referral (counseling and a referral note) or standard referral plus SMS text message (short message service, SMS); those not linked to care within 2 weeks will be rerandomized to receive an additional SMS text message or a one-time financial incentive (approximately US $4). We will also evaluate a primary prevention messaging intervention to support identified high-risk HIV-negative AGYW to reduce their HIV risk and adhere to HIV retesting recommendations. We will also conduct analyses to determine the incremental cost-effectiveness of the seek, testing and linkage interventions.ResultsWe expect to enroll 1200 participants overall, with a random selection of 100 high-risk HIV-negative AGYW for the SMS prevention intervention (HIV-negative cohort) and approximately 108 AGYW who are living with HIV for the SMART design pilot of adaptive linkage to care interventions (HIV-positive cohort). We anticipate that the linkage to care interventions will be feasible and acceptable to implement. Lastly, the use of SMS text messages to engage participants will provide pilot data to the Kenyan government currently exploring a national platform to track and support linkage, adherence to treatment, retention, and prevention interventions for improved outcomes.ConclusionsLessons learned will inform best approaches to identify new HIV diagnoses to increase AGYW’s uptake of HIV prevention, testing, and linkage to care services in a high HIV-burden African setting.Trial RegistrationClinicalTrials.gov NCT02735642; https://clinicaltrials.gov/ct2/show/NCT02735642 (Archived by WebCite at http://www.webcitation...

Screening for HIV and linkage to care in adolescents: insights from a systematic review of recent interventions in high- versus low- and middle-income settings

“…Other investigators are exploring the use of oral, self-testing with video counseling for transgender youth in the US 80. In Kenya, a large-scale study is evaluating alternative testing venues (community versus home) and testing modalities such as oral self-testing, home testing, mobile testing, or facility-based testing 81. Results of these studies may add valuable information for the development of multicomponent interventions to increase HIV testing among adolescents.…”

Preferred HIV Testing Modalities Among Adolescent Girls and Young Women in Kenya

“…Study procedures [18] were approved by Kenyatta National Hospital/University of Nairobi Ethics and Research Committee and Yale University's Human Investigation Committee.…”

“…We hypothesized that preferences around testing venue and testing modalities can be identified that yield a higher proportion of "high-risk" HIVnegative and previously undiagnosed HIV-positive AGYW. Our study design (described elsewhere [18]) assessing recruitment, testing, and linkage to care strategies addresses the seek-testtreat elements critical to the 95-95-95 goal. In this study, we report baseline findings for recruitment and testing preferences among AGYW in Homa Bay County, Nyanza region, western Kenya, which has an HIV prevalence of 20.7% (in comparison to 4.9% for Kenya overall) [4].…”

eHealth to Enhance Treatment Adherence Among Youth Living with HIV

“…Just-in-time adaptive interventions (JITAI) and sequential multiple assignment randomized trials (SMART) have numerous advantages over traditional trial designs and are an efficient and rigorous way to maximize clinical utility and real-world applicability [55–57]. While no completed studies in this review utilized these proposed methodologies, one published study protocol described a forthcoming trial in which newly diagnosed adolescent girls will be enrolled in a SMART pilot trial to determine the most effective way to support initial linkage to care after a positive diagnosis [58]. They will be randomized to standard referral (counseling and a referral note) or standard referral plus a single SMS text message; those not linked to care within 2 weeks will be re-randomized to receive an additional SMS text message or a one-time financial incentive.…”