Table 2.
CWG | ||||||||
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Mutual understanding of meaningful community involvement and scope | Community involvement processes understood | Network CWG, CRS CABs and external community stakeholders informed of community engagement processes | ✓ | ✓ | ✓ | Generated understanding of and support for the HPTN 064 research initiatives. | ||
Research goals are clear and relevant | CAB/Stakeholders buy-in sought prior to completing 064 CRS application | ✓ | ||||||
Strong research community partnerships | Community-investigator partnership is strong | Bi-directional information exchange between community and researchers | ✓ | ✓ | ✓ | ✓ | ✓ | Created culturally responsive community/research partnership with formal structures Funded grant with university and community co-principal- investigators |
Community representatives appointed to the protocol team | ✓ | ✓ | ||||||
All partners receive equal respect | Ongoing training in good clinical practice and human protections | ✓ | ✓ | |||||
Informed consent documents reviewed for accuracy and readability | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Regular study updates provided | ✓ | ✓ | ✓ | |||||
Equitable power | Communities and investigators share power and responsibility equitably | Development of HPTN 064 CWG | ✓ | ✓ | ✓ | ✓ | Identified potential barriers to study implementation Strengthened overall study design Developed culturally appropriate study materials Completed accrual in 14 months 94% participant retention rate |
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Study specific trainings to ensure understanding of the protocol and procedures | ✓ | ✓ | ✓ | ✓ | ||||
Review qualitative data and developed qualitative data analysis code book | ✓ | ✓ | ✓ | ✓ | ||||
Local ethnography to inform recruitment venue selection | ✓ | ✓ | ||||||
Data collection forms reviewed ensure understanding and readability | ✓ | ✓ | ✓ | ✓ | ||||
Diverse perspectives and populations are included in an equitable manner | Substantive feedback integrated into protocol | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Input on development of recruitment and retention plans | ✓ | ✓ | ✓ | |||||
Cultural responsiveness training Submission and selected of study logo | ✓ | ✓ | ✓ | ✓ | ✓ | |||
✓ | ||||||||
Identification of additional community stakeholders | ✓ | ✓ | ||||||
Capacity building | The research project is mutual benefit for all partners | Developed community resource guide | ✓ | ✓ | Established participant referral systems Provision of trained HIV counselors and phlebotomist to provide testing at community events sponsored by partnering agencies Distribution of study information and condoms at community events |
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HPTN 064 CWG training | ✓ | ✓ | ✓ | |||||
Community partnerships established | ✓ | ✓ | ||||||
Volunteerism at community events and supported local businesses | ✓ | |||||||
Communities and investigators have opportunities to build capacity | Personal safety trainings | ✓ | ✓ | |||||
Retention workshop | ✓ | ✓ | ✓ | |||||
Community research priorities to inform network research agenda | ✓ | ✓ | ✓ | ✓ | ||||
Effective dissemination | Transparent results dissemination process | Communication plan and informative materials developed | ✓ | ✓ | ✓ | ✓ | ✓ | Study results released to study participants and scientific community simultaneously Developed culturally appropriate study dissemination materials 36 traditional and social media outlets reported on primary study findings CWG representatives produced a total of 10 abstracts for HIV prevention conferences that were accepted as posters (2), oral presentations (6), and workshops (2) |
Partners develop appropriate dissemination materials and identify appropriate distribution platforms | Network CWG and local CABs were informed of data release timeline | ✓ | ✓ | |||||
Input provided on the development of community results brochure and fact sheet | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Press release reviewed and participation in social media study related messaging | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Presentations provided during local community gratitude celebrations to inform of study results | ✓ | ✓ | ||||||
HPTN 064 national and local study results | ✓ | ✓ | ✓ | |||||
HPTN 064 documentary video | ✓ | ✓ | ✓ | ✓ | ||||
Inclusion of community representatives on manuscript writing teams | ✓ | ✓ | ✓ | |||||
Presentations at national HIV prevention conferences | ✓ | ✓ | ✓ | ✓ |
ACASI = audio computer-assisted self-interview; CAB = community advisory board; CBO = community-based organization; CRS = clinical research site; CWG = community working group; HIV = human immunodeficiency virus; HPTN = HIV Prevention Trials Network; LOC = HPTN leadership and operations center; NIH = National Institutes of Health.
Comprehensive outcomes: improved community rapport and newly established partnerships with community stakeholders through engagement of 56 national and local community stakeholder organizations during the protocol conceptualization, implementation, and dissemination phases of the HPTN 064 protocol. The Comprehensive Outcomes for the HPTN 064 study emerged from the confluence of all these elements.