Rhodes 2011.
Methods |
Study design: cluster RCT Sampling frame: adult Latino males in rural central North Carolina Sampling method: random; participants recruited from community locations frequented by Latinos Description of the community coalition: community‐based participatory research partnership of more than 50 members located mainly in northwest and central North Carolina. Members represent the lay community, including African American/black, Latino, and white gay men; organizational representatives; and academic researchers. Partnership has numerous studies ongoing |
|
Participants |
Communities: rural central North Carolina Country: USA Ages included in assessment: 18+ (n = 139) Reasons provided for selection of intervention community: Latinos in USA disproportionately affected by HIV/AIDS, North Carolina has one of the fastest growing Latino populations Intervention community (population size): rural central North Carolina (unknown) Comparison community (population size): rural central North Carolina (unknown) |
|
Interventions |
Name of intervention: HoMBReS‐2 (Hombres Manteniendo Bienestar y Relaciones Saludables‐2) Theory: Social Cognitive and Education Empowerment Aim: to test the efficacy of a small‐group HIV prevention intervention regarding condom use and HIV testing behavior Description of costs and resources: not provided Components of the intervention: 2 small group sessions involving trust‐building activities, didactic teaching, DVD modules, role plays, and group discussion, as well as skills building, practice, and feedback Start date: not provided Duration: 2 sessions |
|
Outcomes |
Outcomes and measures (follow‐up months)
Years of pre and post measurements: not provided |
|
Notes | Participants entered the study and were randomly assigned in waves to avoid delays between recruitment and intervention delivery. Unclear why missing outcome data appear extensive | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization occurred in waves; each participant selected an envelope from a discrete pool of assignments during each wave |
Allocation concealment (selection bias) | High risk | No allocation concealment |
Baseline outcome measurement similar | High risk | Consistent condom use much greater in intervention group (34.7%) than in control group (21.4%) at baseline |
Baseline characteristics similar | Unclear risk | Intervention group significantly younger; all other presented characteristics appeared similar |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding |
Incomplete outcome data (attrition bias) All outcomes | High risk | Very low rate of loss to follow‐up reported, but final outcome measures show extensive missing observations |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
Protection against contamination | High risk | No protection against contamination was detailed; 6 participants attended the incorrect intervention arm |
Selective reporting (reporting bias) | Low risk | Main outcomes reported |