Trial Outcomes & Findings for A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa (NCT NCT04793217)
NCT ID: NCT04793217
Last Updated: 2026-08-28
Results Overview
HIV-1 RNA viral load (COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0, Roche). Viral suppression defined as \<50 copies/ml. Continuous measures of viral load, modeled using a log10 transformation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
350 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2026-08-28
Participant Flow
350 participants were enrolled. One participant withdrew from the study prior to randomization and thus is not counted here. Randomization occurred at the participant level. No units other than participants were assigned in this study.
Participant milestones
| Measure |
Improving AIDS Care After Trauma+
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
174
|
|
Overall Study
Four Month Follow-up Assessment
|
119
|
122
|
|
Overall Study
Eight Month Follow-up Assessment
|
117
|
125
|
|
Overall Study
COMPLETED
|
127
|
123
|
|
Overall Study
NOT COMPLETED
|
48
|
51
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa
Baseline characteristics by cohort
| Measure |
Improving AIDS Care After Trauma+
n=173 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=172 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
Total
n=345 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 9.4 • n=31 Participants
|
33.4 years
STANDARD_DEVIATION 9.3 • n=49 Participants
|
33.2 years
STANDARD_DEVIATION 9.3 • n=80 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=31 Participants
|
172 Participants
n=49 Participants
|
345 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Black African
|
171 Participants
n=31 Participants
|
170 Participants
n=49 Participants
|
341 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Other - Coloured
|
2 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
|
PTSD (PCL-5)
|
40.3 score on a scale
STANDARD_DEVIATION 19.3 • n=31 Participants
|
39.1 score on a scale
STANDARD_DEVIATION 19.2 • n=49 Participants
|
39.7 score on a scale
STANDARD_DEVIATION 19.2 • n=80 Participants
|
|
Coping
Avoidant Coping
|
2.7 points
STANDARD_DEVIATION 0.8 • n=31 Participants
|
2.8 points
STANDARD_DEVIATION 0.7 • n=49 Participants
|
2.75 points
STANDARD_DEVIATION 0.7 • n=80 Participants
|
|
Coping
Active Coping
|
3.4 points
STANDARD_DEVIATION 0.7 • n=31 Participants
|
3.3 points
STANDARD_DEVIATION 0.7 • n=49 Participants
|
3.3 points
STANDARD_DEVIATION 0.7 • n=80 Participants
|
|
Coping
Social/Spiritual Coping
|
2.2 points
STANDARD_DEVIATION 0.8 • n=31 Participants
|
2.3 points
STANDARD_DEVIATION 0.8 • n=49 Participants
|
2.2 points
STANDARD_DEVIATION 0.8 • n=80 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The primary outcome was only assessed at the 12-month assessment. Those 250 that completed the assessment and those individuals who did not attend their final assessment but had viral loads at 12 months in the National Health Laboratory Service database were included in the analytic sample.
HIV-1 RNA viral load (COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0, Roche). Viral suppression defined as \<50 copies/ml. Continuous measures of viral load, modeled using a log10 transformation.
Outcome measures
| Measure |
Improving AIDS Care After Trauma+
n=132 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=127 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
Number of Participants With Viral Suppression at the 12-month Assessment
|
124 Participants
|
107 Participants
|
SECONDARY outcome
Timeframe: up to 12 MonthsPopulation: In order to be analyzed, individuals needed to have scheduled visits in their medical record. Individuals who only had unscheduled visits in their record are not included in the analysis.
The number of participants with missed visits as determined by medical record review. A missed visit was defined as missing a scheduled visit by more than two weeks from the scheduled date, which aligned with the clinics' definition.
Outcome measures
| Measure |
Improving AIDS Care After Trauma+
n=169 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=167 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
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|---|---|---|
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HIV Care Engagement - Number of Participants With Missed Visits
2 Missed Visits
|
17 Participants
|
18 Participants
|
|
HIV Care Engagement - Number of Participants With Missed Visits
3+ Missed Visits
|
6 Participants
|
8 Participants
|
|
HIV Care Engagement - Number of Participants With Missed Visits
0 Missed Visits
|
97 Participants
|
97 Participants
|
|
HIV Care Engagement - Number of Participants With Missed Visits
1 Missed Visit
|
49 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsVisit adherence defined as the number of scheduled visits attended.
Outcome measures
| Measure |
Improving AIDS Care After Trauma+
n=173 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=172 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
HIV Care Engagement- Visit Adherence
|
6 Number of Visits
Interval 4.0 to 7.0
|
6 Number of Visits
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsGaps in care defined as whether \>90 days have elapsed between visits without sufficient numbers of pills given to cover the gap, as determined by medical record abstraction.
Outcome measures
| Measure |
Improving AIDS Care After Trauma+
n=173 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=172 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
HIV Care Engagement- Number of Participants With Gaps in Care
|
19 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsVisit constancy defined as the number of 90-day intervals with \>1 completed visit, determined by medical record abstraction.
Outcome measures
| Measure |
Improving AIDS Care After Trauma+
n=173 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=172 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
HIV Care Engagement- Visit Constancy
|
3 90-day intervals with >1 completed visit
Interval 1.0 to 4.0
|
3 90-day intervals with >1 completed visit
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Individuals who had their 12-month assessments done telephonically were not able to give samples for Dried Blood Spot analyses.
Dried blood spots measuring levels of tenofovir-diphosphate, dichotomized as adherent or non-adherent based on a cutoff of 400 fmol/punch.
Outcome measures
| Measure |
Improving AIDS Care After Trauma+
n=122 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=118 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
Number of Participants With ART Adherence - Dried Blood Spots
|
93 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsART adherence as defined by the number of pharmacy visits. Determined through medical record abstraction.
Outcome measures
| Measure |
Improving AIDS Care After Trauma+
n=173 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=172 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
ART Adherence - Pharmacy Visits
|
7 Number of Pharmacy Visits
Interval 4.0 to 8.0
|
6 Number of Pharmacy Visits
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsART adherence as defined by pharmacy refill data, total number of pills dispensed. Determined through medical record abstraction.
Outcome measures
| Measure |
Improving AIDS Care After Trauma+
n=173 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=172 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
ART Adherence - Total Number of Pills Dispensed
|
336 Number of Pills
Interval 168.0 to 420.0
|
336 Number of Pills
Interval 154.0 to 420.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 12 MonthsSelf report, measured by Coping Strategies scale (Sikkema et al., 2018; based on Carver, 1997; Folkman \& Lazarus, 1988; Hansen et al., 2013; Namir et al., 1987). Coping will be assessed using 41 items that were previously used to measure coping in Sub-Saharan Africa or among HIV-infected individuals. Participants will be asked how often they used these strategies in the past month to help deal with their HIV illness (1 = not at all to 4 = most of the time).
Outcome measures
| Measure |
Improving AIDS Care After Trauma+
n=127 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=123 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
Coping Strategies Scale Score
Avoidant Coping
|
1.7 score on scale
Standard Deviation 0.6
|
1.7 score on scale
Standard Deviation 0.6
|
|
Coping Strategies Scale Score
Active Coping
|
3.3 score on scale
Standard Deviation 0.5
|
3.2 score on scale
Standard Deviation 0.5
|
|
Coping Strategies Scale Score
Social/Spiritual Coping
|
2.3 score on scale
Standard Deviation 0.6
|
2.2 score on scale
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 12 MonthSelf report, measured by PTSD Checklist-Civilian version for the The Diagnostic and Statistical Manual of Mental Disorders (DSM-5; Blevins CA, Weathers FW, Davis MT, Witte TK, and Domino JKL, 2015). PCL-5, a 20-item self-report questionnaire, will assess severity of symptoms that parallel DSM-5 diagnostic criteria for PTSD. Participants will be asked to indicate the extent to which they were bothered by problems experienced in the past month in relation to a traumatic experience of abuse or act of violence (0 = not at all to 4 = extremely). The total score ranges from 0-80.
Outcome measures
| Measure |
Improving AIDS Care After Trauma+
n=127 Participants
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=123 Participants
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
Traumatic Stress Score
|
12.2 score on scale
Standard Deviation 16.6
|
10.4 score on scale
Standard Deviation 13.7
|
Adverse Events
Improving AIDS Care After Trauma+
Serious events: 21 serious events
Other events: 0 other events
Deaths: 1 deaths
Adapted Problem-Solving Therapy
Serious events: 7 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Improving AIDS Care After Trauma+
n=173 participants at risk
ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.
|
Adapted Problem-Solving Therapy
n=172 participants at risk
Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization - Pregnancy Related
|
6.9%
12/173 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
2.3%
4/172 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
|
Social circumstances
Intimate Partner Violence
|
0.58%
1/173 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
0.58%
1/172 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/173 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
0.58%
1/172 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
|
Social circumstances
Sexual Trauma
|
1.2%
2/173 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
0.00%
0/172 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
|
Social circumstances
Community Violence
|
1.2%
2/173 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
0.00%
0/172 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
|
General disorders
Hospitalizations (unrelated to pregnancy)
|
2.3%
4/173 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
0.58%
1/172 • from enrollment until end of follow-up at around 12 months
In our study, any hospitalization was considered a serious adverse event. However, as we recruited pregnant participants, hospitalizations related to delivery or pregnancy complications were included as serious adverse events. Greater numbers of reported adverse events may by due to greater levels of interaction with ImpACT+ participants due to maintenance visits. No events in this study were deemed by either review board (UCT HREC, CU IRB) to be related to participation in the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Kathleen Sikkema
Columbia University Mailman School of Public Health
Phone: 212-305-8236
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place