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Table 1 Implementation strategies for couples-focused sexual and reproductive health research

From: Methodological strategies to engage young black and Latino heterosexual couples in sexual and reproductive health research

Implementation StrategiesSteps for Successful Implementation
Study Development
Assemble community and youth advisory boards (C/YAB) and hold meetings to receive guidance on study development and implementation• Identify key community stakeholders through online searches for youth-serving organizations, community walkthroughs, and/or referrals.
• Target individuals who are from the target population, work and/or live in the target communities, have experience working directly with the target population, and/or have a strong background in youth SRH.
• Develop C/YAB-specific recruitment materials such as flyers, informational sheets about the study, etc.
• Elicit feedback on study development and implementation including optimal recruitment and retention strategies.
• Provide incentives (i.e., financial compensation, food/refreshments, etc.) to compensate CAB members for their time and insights.
• Develop and/or revise study materials based on feedback.
Pilot test screening methods and study instruments• Recruit and screen individuals from the targeted communities.
• Analyze screening data to assess the feasibility of reaching youth who met the study eligibility criteria.
• Facilitate the full study protocol to elicit feedback on youths’ comprehension of study materials (i.e., ambiguous wording, awkward instructional sets, and non-youth-friendly language) and revise accordingly.
• Provide constructive feedback to the interview facilitation team (i.e., research assistants, interviewers, etc.) to improve their consent and survey administration procedures and interview techniques.
Develop measures to support participants’ physical and emotional well-being• Develop a protocol for addressing emotional distress and reports of child/sexual abuse.
• Develop a community resource guide containing information on sexual and reproductive and behavioral health services in the targeted communities.
Special Considerations for Couples
Develop measures to protect couples’ privacy and confidentiality• Obtain a certificate of confidentiality from the funding agency that legally protects the research team from sharing couples’ information with anyone not affiliated with the study team.
• Secure research space that has nonadjacent rooms to ensure that couple members’ information remains confidential during concurrent facilitation of the individual interviews.
• Hire different qualitative interviewers (when possible) for each interview session to ensure the confidentiality of couples’ information (e.g., one interviewer for male individual interview; one interviewer for female individual interview; one interviewer for dyadic interview).
Special Considerations for Minors
Determine whether to obtain or waive parental consent• Conduct a thorough review of the literature on medical, legal, and ethical considerations regarding obtaining and waiving parental consent, including minors’ ability to consent to research.
• Consult C/YAB on the feasibility of obtaining parental consent and the acceptability of waiving parental consent.
• Review state laws on:
o minors’ ability to consent to the receipt of sexual and reproductive health services (e.g., HIV/STI testing, contraception).
o the legal age at which an individual can consent to participation in sexual activity.
o mandatory reporting requirements for statutory rape.
• Attend IRB consultation sessions prior to protocol submission to discuss considerations for requesting waiver of parental consent for SRH research.
If obtaining parental consent: ensure that all parental materials do not disclose minors’ relationship status and explicitly state that minors’ information would not be shared with parents/guardians.
If requesting a waiver of parental consent: provide the context regarding a request for a waiver of parental consent such as protecting minors’ privacy regarding their involvement in dating relationships, laws supporting minors’ ability to consent to their own sexual and reproductive health services (if applicable), and potential implications of requiring parental consent such as decreased interest in study participation.
Study Implementation
Develop a tracking database for eligible participants/couples• Create an online participant tracking database in data management system (e.g., REDCap).
• Keep detailed notes on each participants’ screening and re/scheduling communication, including date, time, name of research staff, contact method(s) used, synopsis of the interaction, and next steps.
• Link couples’ information by couple ID number.
Develop a locator form to maintain contact with eligible participants• Require all eligible participants to complete a locator form, which includes: preferred name, contact information (address, phone number, email address, social media handle, etc.), name and contact information of someone who always knows how to reach the participant, preferred contact methods, best time to contact the participant (day [s] of the week and time of day), and availability to participate in the study activities.
• Encourage participants to provide at least three reliable contact methods. Reassure participants that all collected information will remain confidential and not be shared with anyone outside of the research team, including parent(s)/guardians or nominated partner.
• Review the locator form with the participants to ensure that the information provided was complete, legible, and accurate.
• Collect other important contextual notes (i.e., participants school/work schedules, family obligations, etc.).
• Enter contact information in REDCap immediately following each recruitment session.
Create a database for the availability of project staff• Create a project-specific Google calendar.
• Confirm the availability of the research team and research space prior to scheduling interview session with couple.
• Send calendar invitations to the interview team following appointment confirmation. Pertinent information includes:
o interview time, date, and location.
o directions to the interview location.
o role/assignments (i.e., individual male/female interviewer, dyadic interviewer, research assistant).
o couples’ and interview teams’ contact information.
Secure appropriate resources (i.e., research space, staff, etc.)• Assess space needs including accessibility to public transportation, operating hours (i.e., day, evening, and weekend availability), protection of couples’ privacy/confidentiality, etc.
• Assess staffing needs based on study needs (i.e., participant recruitment, facilitation of the interview session, etc.), protection of couples’ privacy/confidentiality, targeted recruitment goal and timeline, budget.
• Consider hiring staff that are: members of the target population (race/ethnicity, age, residence), have prior experience working with the target population and/or in the target communities, background in and strong commitment to sexual and reproductive health issues, and flexible work schedules and availability congruent with the target population (i.e., evenings, weekends).
• Hold training sessions with all study staff on proper recruitment/retention and study facilitation procedures. Include role-playing to increase comfort engaging with the target population.