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Behavioural Intervention

Group vs Individual Interventions for HIV Prevention

N/A
Recruiting
Led By Bisola O. Ojikutu, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages between 18 and 45
Cis-gender woman
Must not have
Cis-gender man
Transgender man
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month and 6-months after intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to reduce HIV diagnosis rates among African-born Black women in the US by adapting two HIV prevention interventions & testing their effectiveness with a randomized trial.

Who is the study for?
This trial is for HIV-negative, African-born Black or mixed-Black cis-gender women aged 18-45 living in Greater Boston Area or New York City. Participants must speak English or French and have had unprotected sex recently. Pregnant women, men, and transgender individuals cannot join.
What is being tested?
The study tests two adapted HIV prevention interventions: 'Dada Kwa Dada' (DKD) for individual-level education and 'DADA' for group sessions. Both aim to increase condom use and PrEP uptake among participants to reduce HIV/STI incidence.
What are the potential side effects?
Since the interventions involve educational activities rather than medical treatments, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I am a cisgender woman.
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I have had unprotected sex with a man in the past 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a cisgender man.
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I am a transgender man.
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I am a transgender woman.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month and 6-months after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month and 6-months after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants who are willing to take PrEP in the next 12 months.
Proportion of participants who obtained PrEP prescriptions.
Proportion of participants who took PrEP through pill or injection.
+1 more
Secondary study objectives
Proportion of participants who accepted HIV testing.
Proportion of participants who tested positive for STI.
Proportion of participants with intention to get tested for HIV in the next 6 months.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group-level interventionExperimental Treatment1 Intervention
Virtual group sessions
Group II: Individual-level interventionActive Control1 Intervention
Virtual one-on-one session

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
575 Previous Clinical Trials
27,079,038 Total Patients Enrolled
Boston UniversityOTHER
473 Previous Clinical Trials
9,990,409 Total Patients Enrolled
RANDOTHER
141 Previous Clinical Trials
614,541 Total Patients Enrolled
~156 spots leftby Jun 2025
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