ABSTRACT
BACKGROUND:
Gay,
bisexual, and other men who have sex with men (MSM), particularly
Black or African American MSM (BMSM) and
Hispanic or Latino MSM (HLMSM), continue to be disproportionately affected by the
HIV epidemic in the
United States. Previous
HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled
White, non-
Hispanic MSM.
Mobile health tools can support
HIV prevention, testing, and
treatment. This protocol details an implementation study of mailing free
HIV self-tests (HIVSTs) nested within a
randomized controlled trial designed to assess the benefit of a
mobile phone app for increasing the uptake of
HIV prevention and other
social services.
OBJECTIVE:
This study was a comparative
effectiveness trial of innovative recruitment and testing promotion
strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a
mobile app for increasing
access to care.
METHODS:
Study development began with individual and group
consultations that elicited
feedback from 3 core groups
HIV care practitioners and
researchers,
HIV service
organization leaders from study states, and BMSM and HLMSM living in the study states. Upon completion of the formative qualitative
work, participants from 11 states, based on the observed areas of highest rate of new
HIV diagnoses among Black and
Hispanic MSM, were recruited through
social networking websites and
smartphone apps. After eligibility was verified, participants consented and were randomized to the intervention
arm (access to the Know@Home
mobile app) or the control
arm (
referral to web
resources). We provided all participants with HIVSTs. The evaluation of the
efficacy of a
mobile phone app to support linkage to posttest prevention services that included
sexually transmitted infection testing,
pre-exposure prophylaxis initiation, antiretroviral
treatment, and acquisition of
condoms and compatible
lubricants has been planned. Data on these outcomes were obtained from several sources, including HIVST-
reporting surveys, the 4-month follow-up
survey,
laboratory analyses of dried
blood spot cards returned by the participant, and data obtained from the
state health department
surveillance systems. Where possible, relevant subgroup analyses were performed.
RESULTS:
During the formative development phase, 9
consultations were conducted 6 in-depth individual discussions and 3 group
consultations. From February 2020 through February 2021, we enrolled 2093 MSM in the
randomized controlled trial from 11 states, 1149 BMSM and 944 HLMSM.
CONCLUSIONS:
This study was designed and implemented to evaluate the
effectiveness of recruitment
strategies to reach BMSM and HMSM and of a
mobile app with regard to linkage to
HIV prevention or
treatment services. Data were also obtained to allow for the analyses of
cost and
cost-
effectiveness related to study enrollment,
HIV testing uptake, identification of previously undiagnosed
HIV,
sexually transmitted infection testing and
treatment, and linkage to
HIV prevention or
treatment services. TRIAL REGISTRATION ClinicalTrials.gov (NCT04219878); https//clinicaltrials.gov/ct2/show/NCT04219878. INTERNATIONAL
REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/43414.
