Trial Outcomes & Findings for Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa (NCT NCT04242992)
NCT ID: NCT04242992
Last Updated: 2026-02-19
Results Overview
The proportion of participants who are virally suppressed (\<50 copies/mL) by 12 months post randomization
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
399 participants
Primary outcome timeframe
12 months post randomization
Results posted on
2026-02-19
Participant Flow
Note that partners are not enrolled in the study, they are only enrolled in CETA and as such are not study subjects.
Participant milestones
| Measure |
CETA (Common Elements Treatment Approach)
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
Active Control
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
|---|---|---|
|
3 Month Follow up Assesment
STARTED
|
202
|
197
|
|
3 Month Follow up Assesment
COMPLETED
|
156
|
147
|
|
3 Month Follow up Assesment
NOT COMPLETED
|
46
|
50
|
|
12 Month Follow up Assessment
STARTED
|
202
|
197
|
|
12 Month Follow up Assessment
COMPLETED
|
136
|
147
|
|
12 Month Follow up Assessment
NOT COMPLETED
|
66
|
50
|
Reasons for withdrawal
| Measure |
CETA (Common Elements Treatment Approach)
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
Active Control
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
|---|---|---|
|
3 Month Follow up Assesment
Did not complete 3 month assessment
|
46
|
50
|
|
12 Month Follow up Assessment
Did not complete 12 month assessment
|
66
|
50
|
Baseline Characteristics
Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa
Baseline characteristics by cohort
| Measure |
CETA (Common Elements Treatment Approach)
n=202 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
Active Control
n=197 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
40.9 years
STANDARD_DEVIATION 9.3
|
40.6 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=4 Participants
|
197 Participants
|
399 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black African
|
196 Participants
n=4 Participants
|
192 Participants
|
388 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Coloured
|
2 Participants
n=4 Participants
|
5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
4 Participants
n=4 Participants
|
0 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
202 participants
n=4 Participants
|
197 participants
|
399 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 months post randomizationPopulation: Since this outcome was determined using medical records data, the available denominators for each arm are the original numbers randomized.
The proportion of participants who are virally suppressed (\<50 copies/mL) by 12 months post randomization
Outcome measures
| Measure |
Active Control
n=197 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=202 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
12 Month Viral Suppression
|
86 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: 3 months post randomizationPopulation: 55 of the 202 CETA participants and 34 of the 197 Control participants had a viral load at 3 months for analysis
The proportion of participants who are virally suppressed (\<50 copies/mL) by 3 months post randomization of those with a viral load at 3 months of follow-up
Outcome measures
| Measure |
Active Control
n=34 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=55 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
3 Month Viral Suppression
|
13 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 12 months post randomizationAttrition rate (the opposite of retention) will be defined as the proportion of participants being more than 90 days late for a study visit 12 months post randomization.
Outcome measures
| Measure |
Active Control
n=197 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=202 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
12 Month Attrition Rate
|
38 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 3 monthsViolence will be measured using the Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, a 27 item measure with a possible range of 27-108 and higher scores associated with greater severity of experienced violence.
Outcome measures
| Measure |
Active Control
n=147 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=156 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
Violence Against Women at 3 Months
|
37.0 score on a scale
Interval 35.6 to 38.4
|
37.0 score on a scale
Interval 35.3 to 38.9
|
SECONDARY outcome
Timeframe: 12 monthsViolence will be measured using the Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, a 27 item measure with a possible range of 27-108 and higher scores associated with greater severity of experienced violence.
Outcome measures
| Measure |
Active Control
n=147 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=136 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
Violence Against Women at 12 Months
|
37.1 score on a scale
Interval 35.4 to 38.8
|
35.2 score on a scale
Interval 33.9 to 36.6
|
SECONDARY outcome
Timeframe: 3 monthsSubstance use will be measured with the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which includes 7 items on frequency of use, abuse, and dependence symptoms for the following substance types: tobacco, alcohol, inhalants, marijuana, cocaine, amphetamines, sedatives, hallucinogens, opioids , or other substance. Higher scores are associated with greater substance involvement. ASSIST is a binary outcome of yes/no to any past-three month substance use, it is not a continuous measure. Scores can range from 0 to 1.
Outcome measures
| Measure |
Active Control
n=147 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=156 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
Substance Use at 3 Months
|
0.1 score on a scale
Interval 0.1 to 0.2
|
0.1 score on a scale
Interval 0.08 to 0.2
|
SECONDARY outcome
Timeframe: 12 monthsSubstance use will be measured with the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which includes 7 items on frequency of use, abuse, and dependence symptoms for the following substance types: tobacco, alcohol, inhalants, marijuana, cocaine, amphetamines, sedatives, hallucinogens, opioids , or other substance. Higher scores are associated with greater substance involvement. ASSIST is a binary outcome of yes/no to any past-three month substance use, it is not a continuous measure. Scores can range from 0 to 1.
Outcome measures
| Measure |
Active Control
n=147 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=136 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
Substance Use at 12 Months
|
0.2 score on a scale
Interval 0.1 to 0.3
|
0.1 score on a scale
Interval 0.06 to 0.2
|
SECONDARY outcome
Timeframe: 3 monthsPTSD symptoms will be assessed using 16 items scored on a four-point scale (1 = none, 2 = some of the time, 3 = a lot of the time, 4 = most of the time) from the Harvard Trauma Questionnaire (HTQ). HTQ scores can range from 1-4. Higher scores are associated with greater PTSD symptom severity.
Outcome measures
| Measure |
Active Control
n=147 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=156 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
Post-traumatic Stress Disorder (PTSD) Symptoms at 3 Months
|
1.8 score on a scale
Interval 1.7 to 1.9
|
1.6 score on a scale
Interval 1.5 to 1.7
|
SECONDARY outcome
Timeframe: 12 monthsPTSD symptoms will be assessed using 16 items scored on a four-point scale (1 = none, 2 = some of the time, 3 = a lot of the time, 4 = most of the time) from the Harvard Trauma Questionnaire (HTQ). HTQ scores can range from 1-4. Higher scores are associated with greater PTSD symptom severity.
Outcome measures
| Measure |
Active Control
n=147 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=136 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
Post-traumatic Stress Disorder (PTSD) Symptoms at 12 Months
|
1.9 score on a scale
Interval 1.8 to 2.0
|
1.7 score on a scale
Interval 1.6 to 1.9
|
SECONDARY outcome
Timeframe: 3 monthsCES-D is a 20-item scale of depression with a possible range of 0-60 (total scale score). Higher scores are associated with greater depression symptom severity.
Outcome measures
| Measure |
Active Control
n=147 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=156 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 3 Months
|
16.1 score on a scale
Interval 14.4 to 17.7
|
15.3 score on a scale
Interval 13.4 to 17.2
|
SECONDARY outcome
Timeframe: 12 monthsCES-D is a 20-item scale of depression with a possible range of 0-60 (total scale score). Higher scores are associated with greater depression symptom severity.
Outcome measures
| Measure |
Active Control
n=147 Participants
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
CETA (Common Elements Treatment Approach)
n=136 Participants
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
|---|---|---|
|
Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 12 Months
|
20.1 score on a scale
Interval 18.2 to 22.1
|
16.7 score on a scale
Interval 14.7 to 18.7
|
Adverse Events
CETA (Common Elements Treatment Approach)
Serious events: 12 serious events
Other events: 0 other events
Deaths: 1 deaths
Active Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CETA (Common Elements Treatment Approach)
n=202 participants at risk
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
|
Active Control
n=197 participants at risk
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for difficulty breathing
|
0.00%
0/202 • 12 months
|
0.51%
1/197 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Hospitalized for suicidal attempt
|
0.99%
2/202 • Number of events 2 • 12 months
|
0.00%
0/197 • 12 months
|
|
Social circumstances
Hospitalized because physically abused
|
0.99%
2/202 • Number of events 2 • 12 months
|
0.00%
0/197 • 12 months
|
|
Reproductive system and breast disorders
Hospitalized for fibroid surgery
|
0.50%
1/202 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Injury, poisoning and procedural complications
Hospitalized for food poisoning
|
0.50%
1/202 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Gastrointestinal disorders
Hospitalized for abdominal pain
|
0.50%
1/202 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Gastrointestinal disorders
Hospitalized for severe diarrhea
|
0.50%
1/202 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
General disorders
Hospitalized for syncope
|
0.50%
1/202 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Social circumstances
Hospitalized for substance induced psychosis
|
0.50%
1/202 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
Psychiatric disorders
Hospitalized for psychotic relapse
|
0.50%
1/202 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
|
General disorders
Hospitalized for car crash
|
0.50%
1/202 • Number of events 1 • 12 months
|
0.00%
0/197 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Matthew Fox, DSc, MPH
Boston University School of Public Health, Epidemiology and Global Health
Phone: 617-358-2062
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place