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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH121998 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the impact of the Common Elements Treatment Approach (CETA), an evidence-based intervention comprised of cognitive-behavioral therapy elements, at improving HIV treatment outcomes among women with HIV who have experienced intimate partner violence (IPV) and have an unsuppressed viral load on HIV treatment. To evaluate CETA, the investigators will conduct a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA in increasing viral suppression and reducing violence. The investigators will also identify mediators and moderators of CETA's effect on retention and viral suppression and assess the cost and cost-effectiveness of CETA vs. active control at increasing the proportion who are retained and virally suppressed by 12 months.
There are just under one million people with HIV in South Africa who have initiated antiretroviral therapy (ART) but remain unsuppressed. South Africa has been making progress towards UNAIDS 90-90-90 targets but currently only 47% of those infected are suppressed. In South Africa, one major barrier to consistent treatment is intimate partner violence (IPV); nearly 50% of women have experienced IPV. The Common Elements Treatment Approach (CETA) is an evidence-based intervention intended to provide coping skills to women who have experienced IPV, and is comprised of cognitive-behavioral therapy elements. It is a transdiagnostic tool that can flexibly address a range of mental health problems (e.g. depression, anxiety) and represents the current best practice in global mental health as a more cost-effective, scalable and sustainable model. CETA is one of the most promising interventions to impact HIV outcomes through addressing the indirect effects of IPV on adherence and continuity of care.
The investigators will conduct a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA, in increasing retention and viral suppression, and reducing violence. The study aim is:
• Among HIV-infected women on ART who have experienced IPV and have an unsuppressed viral load, assess the effectiveness of CETA vs. active control at increasing the proportion retained and virally suppressed by 12 months and at decreasing the severity and incidence of IPV and other mental and behavioral health problems using a randomized trial;
Study staff will obtain full informed consent from those who meet inclusion criteria. For those that agree to participate, study staff will then randomize patients to CETA or control using sealed randomization envelopes. All subjects will be followed for 12 months to ensure data for primary and secondary outcomes is complete. Follow-up HIV data will be passive using routinely collected medical records from the clinics. HIV outcomes will be assessed at 3 and 12-months post-baseline. Questionnaires on violence, substance use, and mental health will be administered at baseline, and at 3 months (following CETA end) and 12 months post-baseline. These include: Severity of Violence Against Women Scale, Center for Epidemiological Studies-Depression Scale, Harvard Trauma Questionnaire, and Alcohol, Smoking, and Substance Involvement Screening Test. The primary outcome will be retention and viral suppression (<50 copies/mL) by 12 months after randomization. Secondary outcomes will include: 1) Viral suppression at 3 months; 2) Attrition at 12 months; and 3) IPV, mental/behavioral health, alcohol and other substance use at 3 and 12 months.
The primary aim is to analyze the impact of CETA in the full study population; however, our sample size was calculated to ensure our ability to detect differences separately among women who include a partner in the CETA intervention and those who do not not (noting that partners are not enrolled in the study, they are only enrolled in CETA and as such are not study subjects). A sample of 400 women will be included which will give us 80% power to detect an absolute 21% difference between arms. The primary analysis will be a comparison of intervention and control by risk differences with 95% confidence intervals. The investigators will analyze direct effects of CETA on continuous outcomes (e.g., mental health) with linear mixed models. The impact of potential moderators on retention and mental health outcomes using interaction terms will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CETA (Common Elements Treatment Approach) | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CETA | Behavioral | CETA is a modular, multi-problem, flexible psychotherapy approach that trains a lay provider in nine evidence-based CBT elements so providers can treat a variety of common problems, including violence, substance use, depression, anxiety, risky behaviors (sexual, non-adherence), and other trauma-related symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| 12 Month Viral Suppression | The proportion of participants who are virally suppressed (<50 copies/mL) by 12 months post randomization | 12 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 3 Month Viral Suppression | 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 | 3 months post randomization |
| 12 Month Attrition Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Fox, DSc | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIV Clinic | Johannesburg | Gauteng | 02476 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41592903 | Derived | Zheng A, Kane JC, Mngadi-Ncube S, Fox MP, Manganye P, Long L, Metz K, Sardana S, Alto M, Greener R, Thea DM, Murray LK, Pascoe S. Effectiveness of the Common Elements Treatment Approach for mental and behavioural health outcomes among women struggling to remain adherent to HIV treatment and who have experienced intimate partner violence in South Africa: secondary outcomes from a randomised controlled trial. BMJ Ment Health. 2026 Jan 27;29(1):e302246. doi: 10.1136/bmjment-2025-302246. | |
| 41282709 |
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Once the research team has had sufficient time to analyze the data and submit the results for the primary study aims, the data will be made available on request in de-identified format for selected outcome measures. Only those original data collected by the study team can be shared, clinical records owned by the government cannot.
Once the primary aims are completed, approximately 12 months after study completion.
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Note that partners are not enrolled in the study, they are only enrolled in CETA and as such are not study subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 Month Follow up Assesment |
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| 12 Month Follow up Assessment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 12 Month Viral Suppression | The proportion of participants who are virally suppressed (<50 copies/mL) by 12 months post randomization | Since this outcome was determined using medical records data, the available denominators for each arm are the original numbers randomized. | Posted | Count of Participants | Participants | 12 months post randomization |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized for difficulty breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Fox, DSc, MPH | Boston University School of Public Health, Epidemiology and Global Health | 617-358-2062 | mfox@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2025 | Dec 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 4, 2025 | Dec 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013097 | Spermine Synthase |
| ID | Term |
|---|---|
| D019883 | Alkyl and Aryl Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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Women will be randomized 1:1 to either CETA or an active attention control arm.
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As the intervention is a behavioral intervention, it will not be possible to blind women to their intervention, but outcome assessors will be blinded.
|
| Short Message Service (SMS) text reminders | Other | Short Message Service (SMS) text reminders for upcoming appointments will be sent monthly. |
|
Attrition 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.
| 12 months post randomization |
| Violence Against Women at 3 Months | Violence 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. | 3 months |
| Violence Against Women at 12 Months | Violence 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. | 12 months |
| Substance Use at 3 Months | Substance 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. | 3 months |
| Substance Use at 12 Months | Substance 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. | 12 months |
| Post-traumatic Stress Disorder (PTSD) Symptoms at 3 Months | PTSD 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. | 3 months |
| Post-traumatic Stress Disorder (PTSD) Symptoms at 12 Months | PTSD 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. | 12 months |
| Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 3 Months | CES-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. | 3 months |
| Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 12 Months | CES-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. | 12 months |
| Zheng A, Kane JC, Mngadi-Ncube S, Fox MP, Manganye P, Long L, Metz K, Sardana S, Alto M, Greener R, Thea DM, Murray LK, Pascoe S. Effectiveness of the Common Elements Treatment Approach (CETA) for mental and behavioral health outcomes among women struggling to remain adherent to HIV treatment and who have experienced intimate partner violence in South Africa: A randomised controlled trial. medRxiv [Preprint]. 2025 Oct 15:2025.10.14.25337970. doi: 10.1101/2025.10.14.25337970. |
| 36549749 | Derived | Pascoe S, Fox M, Kane J, Mngadi S, Manganye P, Long LC, Metz K, Allen T, Sardana S, Greener R, Zheng A, Thea DM, Murray LK. Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa. BMJ Open. 2022 Dec 22;12(12):e065848. doi: 10.1136/bmjopen-2022-065848. |
| NOT COMPLETED |
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|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Active Control | Our comparison arm will be an active control receiving 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. |
|
|
| Secondary | 3 Month Viral Suppression | 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 | 55 of the 202 CETA participants and 34 of the 197 Control participants had a viral load at 3 months for analysis | Posted | Count of Participants | Participants | 3 months post randomization |
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|
|
| Secondary | 12 Month Attrition Rate | Attrition 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. | Posted | Count of Participants | Participants | 12 months post randomization |
|
|
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| Secondary | Violence Against Women at 3 Months | Violence 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months |
|
|
|
| Secondary | Violence Against Women at 12 Months | Violence 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
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|
|
| Secondary | Substance Use at 3 Months | Substance 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months |
|
|
|
| Secondary | Substance Use at 12 Months | Substance 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | Post-traumatic Stress Disorder (PTSD) Symptoms at 3 Months | PTSD 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months |
|
|
|
| Secondary | Post-traumatic Stress Disorder (PTSD) Symptoms at 12 Months | PTSD 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Secondary | Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 3 Months | CES-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. | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months |
|
|
|
| Secondary | Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 12 Months | CES-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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| 1 |
| 202 |
| 12 |
| 202 |
| 0 |
| 202 |
| EG001 | 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. | 2 | 197 | 1 | 197 | 0 | 197 |
| Hospitalized for suicidal attempt | Psychiatric disorders | Systematic Assessment |
|
| Hospitalized because physically abused | Social circumstances | Systematic Assessment |
|
| Hospitalized for fibroid surgery | Reproductive system and breast disorders | Systematic Assessment |
|
| Hospitalized for food poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hospitalized for abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Hospitalized for severe diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Hospitalized for syncope | General disorders | Systematic Assessment |
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| Hospitalized for substance induced psychosis | Social circumstances | Systematic Assessment |
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| Hospitalized for psychotic relapse | Psychiatric disorders | Systematic Assessment |
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| Hospitalized for car crash | General disorders | Systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |