The Young Women's Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV.

BACKGROUND: South Africa remains the global epicentre of HIV infection, and adolescent women have the highest incidence of HIV in the country. South Africa also has high rates of alcohol and other drug (AOD) use, violence, and gender inequality. Violence converges with AOD use, gender inequities and other disparities, such as poverty, to increase sexual risk and poor educational attainment for adolescent women. This study seeks to test the efficacy of peer recruitment and cofacilitation of the Young Women's Health CoOp (YWHC), a comprehensive gender-focused intervention to reduce HIV risk behaviours and increase the uptake of HIV counselling and testing (HCT) among out-of-school, adolescent women who use AODs. The YWHC is facilitated by local research staff and supported by peers. METHODS: This cluster-randomised trial is enrolling participants into two arms: a control arm that receives standard HCT, and an intervention arm that receives the YWHC. Participants are enrolled from 24 economically disadvantaged communities in Cape Town, South Africa. These geographically distinct communities serve as clusters that are the units of randomisation. This study uses adolescent peer role models and research field staff to recruit marginalised adolescent women. At baseline, participants complete a questionnaire and biological testing for HIV, recent AOD use, and pregnancy. The core intervention is delivered in the month following enrollment, with linkages to health services and educational programmes available to participants throughout the follow-up period. Follow-up interviews and biological testing are conducted at 6 and 12 months post enrollment. DISCUSSION: The study findings will increase knowledge of the efficacy of a comprehensive HCT, gender-focused programme in reducing AOD use, victimisation, and sexual risk behaviour and increase uptake services for out-of-school, adolescent women who use AODs. The trial results could lead to wider implementation of the YWHC for vulnerable adolescent women, a key population often neglected in health services. TRIAL REGISTRATION: Trial registration no: NCT02974998 , November 29, 2016.

mHealth versus face-to-face: study protocol for a randomized trial to test a gender-focused intervention for young African American women at risk for HIV in North Carolina.

BACKGROUND: Disparities in the prevalence of HIV persist in the southern United States, and young African American women have a disproportionate burden of HIV as compared with young women of other racial/ethnic backgrounds. As a result, engaging young African American women in the HIV care continuum through HIV testing is imperative. This study is designed to reach this key population at risk for HIV. The study seeks to test the efficacy of two formats of a gender-focused, evidence-based, HIV-risk reduction intervention-the Young Women's CoOp (YWC)-relative to HIV counseling and testing (HCT) among young African American women between the ages of 18 and 25 who use substances and have not recently been tested for HIV. METHODS: Using a seek-and-test framework, this three-arm cross-over randomized trial is being conducted in three county health departments in North Carolina. Each county is assigned to one of three study arms in each cycle: in-person (face-to-face) YWC, mobile Health (mHealth) YWC, or HCT. At study enrollment, participants complete a risk behavior survey via audio computer-assisted self-interview, and drug, alcohol, and pregnancy screening tests, and are then referred to HIV, gonorrhea, and chlamydia testing through their respective health departments. Participants in either of the YWC arms are asked to return approximately 1 week later to either begin the first of two in-person individual intervention sessions or to pick up the mHealth intervention preloaded on a tablet after a brief introduction to using the app. Participants in all arms are asked to return for a 6-month follow-up and 12-month follow-up, and repeat the survey and biological testing from baseline. DISCUSSION: The findings from this study will demonstrate which delivery format (mHealth or face-to-face) is efficacious in reducing substance use and sexual risk behaviors. If found to be efficacious, the intervention has potential for wider dissemination and reach. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02965014 . Registered November 16, 2016.

An Evidence-Based HIV Risk-Reduction Intervention for Young African American Women in the US South Using mHealth: Adaptation and Development Study.

BACKGROUND: Young African American women have higher rates of sexually transmitted infections, including HIV, than those of young women of other racial and ethnic groups. Gender-, culture-, and age-specific interventions are needed to end the HIV epidemic. The Women's CoOp (WC) is an HIV risk-reduction intervention that is proven to be efficacious in various face-to-face formats. OBJECTIVE: This study aims to adapt the delivery method of an evidence-based intervention, the WC, from an in-person format to a self-guided mobile health (mHealth) format while ensuring that core elements are maintained for intervention comparability and fidelity. METHODS: Several adaptation phases were conducted by using the Personal Health Informatics and Intervention Toolkit (PHIT) as a guiding point to create the mobile app version of the WC. Throughout 5 phases, we established the implementation groundwork for the app; conducted formative research activities to test the initial draft of the app and obtain feedback; applied the PHIT toolkit programming structure to produce the mHealth version of the WC intervention; conducted usability testing and pretesting with interested parties, followed by in-house testing by WC interventionists and PHIT developers; and deployed the app to tablets and distributed it to study participants. The app underwent regular maintenance updates during the study. RESULTS: The team converted the seven elements of the WC as accurately as possible for comparability to determine efficacy in a mobile app format while changing little about the basic delivery methods. For instance, cue card presentations of the materials delivered by the intervention staff were presented within the app but with voice-over narration and in a self-guided format rather than being led by a staff member. Other aspects of the intervention did not lend themselves to such straightforward adaptation, such as hands-on condom proficiency practice and one-on-one goal-setting activities. In these cases, the subject matter experts and app developers worked together to find comparable analogs to be used within the app. Once developed, tested, and finalized, the mHealth WC app was deployed into local health departments as part of a randomized trial. CONCLUSIONS: This systematic adaptation process created an accurate mHealth equivalent of an existing, in-person behavioral health intervention. Although participants' reception of the app during the formative developmental phase was overall positive, maintaining fidelity to the in-person delivery compromised the natural capabilities of a mobile app, such as further gamification, different types of interactivity, and integrated notifications and messaging, which could be helpful for participants' adherence to the intervention schedule. Given the development and implementation of the app, the next step is to examine the impact of the app and its efficacy in HIV and substance use risk-reduction.