Trial Outcomes & Findings for Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use (NCT NCT04071470)
NCT ID: NCT04071470
Last Updated: 2024-07-25
Results Overview
Maternal adherence to medication as measured via monthly medication pick up records
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
3 months
Results posted on
2024-07-25
Participant Flow
Participant milestones
| Measure |
Standard of Care
Standard of care for pregnant women at risk of HIV seroconversion includes couples counseling and access to PrEP (women) and ART (men)
PrEP: Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
|
Storytelling Intervention
Participants in this group will receive the same services as those in the SOC but will also be provided three storytelling sessions for themselves and their families as a way to educate and de-stigmatize PrEP services.
Storytelling: Couples in the storytelling intervention will receive 3 storytelling sessions- the couple can include any family or friends who they feel could support them during their treatment. Stories will include stories of couples who are supportive, those who experience difficulties, and families who do/do not support their use of PrEP
PrEP: Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
66
|
|
Overall Study
COMPLETED
|
62
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Storytelling to Increase Family Support for Pre Exposure Prophylaxis Use
Baseline characteristics by cohort
| Measure |
Standard of Care
n=62 Participants
Standard of care for pregnant women at risk of HIV seroconversion includes couples counseling and access to PrEP (women) and ART (men)
PrEP: Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
|
Storytelling Intervention
n=66 Participants
Participants in this group will receive the same services as those in the SOC but will also be provided three storytelling sessions for themselves and their families as a way to educate and de-stigmatize PrEP services.
Storytelling: Couples in the storytelling intervention will receive 3 storytelling sessions- the couple can include any family or friends who they feel could support them during their treatment. Stories will include stories of couples who are supportive, those who experience difficulties, and families who do/do not support their use of PrEP
PrEP: Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.5 years
STANDARD_DEVIATION 5.59 • n=5 Participants
|
25.8 years
STANDARD_DEVIATION 6.64 • n=7 Participants
|
25.1 years
STANDARD_DEVIATION 6.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Occupation
Merchant
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Occupation
Domestic
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Occupation
Farmer
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Occupation
Fisherman
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Occupation
Other
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: We only looked at PrEP use among the women in the study
Maternal adherence to medication as measured via monthly medication pick up records
Outcome measures
| Measure |
Standard of Care
n=31 Participants
Standard of care for pregnant women at risk of HIV seroconversion includes couples counseling and access to PrEP (women) and ART (men)
PrEP: Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
|
Storytelling Intervention
n=33 Participants
Participants in this group will receive the same services as those in the SOC but will also be provided three storytelling sessions for themselves and their families as a way to educate and de-stigmatize PrEP services.
Storytelling: Couples in the storytelling intervention will receive 3 storytelling sessions- the couple can include any family or friends who they feel could support them during their treatment. Stories will include stories of couples who are supportive, those who experience difficulties, and families who do/do not support their use of PrEP
PrEP: Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
|
|---|---|---|
|
Adherence to PrEP Medication
|
96.6 percentage of pills taken daily
Interval 80.6 to 100.0
|
95.5 percentage of pills taken daily
Interval 78.1 to 98.9
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place