HIV/AIDSCETANCT04242992
Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa
A study testing CETA and Short Message Service (SMS) text reminders in people with HIV/AIDS and Violence, run by Boston University at 1 site in South Africa.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- CETA and Short Message Service (SMS) text reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteSouth Africa
- Study dates
- 12 Nov 2021to 23 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult HIV positive women
- Initiated HIV treatment
- Most recent viral load >50 copies/mL or they have defaulted from treatment or had a missed or late (>14 days) visit in the last year
- Has experienced IPV in the past 12 months
- Has their own phone and can receive text messages
- Literate and able to speak and read one of: English, Zulu, SeSotho
- If including a partner, the woman has disclosed HIV status to the partner that will be invited to participate (noting that male partners are not study subjects, only the woman is)
Who cannot join
- Unwilling to complete the informed consent process
- Currently psychotic or on unstable psychiatric regimen
- Suicide attempt/ideation with intent and plan, and/or self-harm in the past month
- Enrolled in any other HIV treatment intervention study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Effectiveness of an Evidence-based Transdiagnostic Cognitive Behavioral Therapy Approach for Improving HIV Treatment Outcomes Among Violence-affected and Virally Unsuppressed Women in South Africa
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.
Read the detailed description
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.
- Being tested
- CETA, Short Message Service (SMS) text reminders
- Keywords
- HIV, Retention, Viral suppression, Violence, Cognitive behavioral therapy (CBT), Common Elements Treatment Approach (CETA)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CETABehavioural
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.
Short Message Service (SMS) text remindersOther
Short Message Service (SMS) text reminders for upcoming appointments will be sent monthly.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CETA; Other: Short Message Service (SMS) text reminders |
| 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. Receives: Other: Short Message Service (SMS) text reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 Month Viral Suppression
The proportion of participants who are virally suppressed (<50 copies/mL) by 12 months post randomization
Measured: 12 months post randomization
Secondary outcomes (10)
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
Measured: 3 months post randomization
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start12 Nov 2021
- Primary completion23 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women will be randomized 1:1 to either CETA or an active attention control arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Matthew Fox, DSc, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242992
- Sponsor's protocol ID
- H-39746
- Other IDs
- 1R01MH121998
- Acronym
- CETA
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2020
- Last updated
- 19 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41592903Zheng 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.
PubMed 41282709Pascoe 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.
PubMed 36549749
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of an Evidence-based Transdiagnostic Cognitive Behavioral Therapy Approach for Improving HIV Treatment Outcomes Among Violence-affected and Virally Unsuppressed Women in South Africa
- ClinicalTrials.gov ID
- NCT04242992
- Acronym / sponsor ID
- CETA / H-39746
- Keywords
- HIV, Retention, Viral suppression, Violence, Cognitive behavioral therapy (CBT), Common Elements Treatment Approach (CETA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 19 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Women will be randomized 1:1 to either CETA or an active attention control arm.
| Arm | Type | Receives |
|---|---|---|
| CETA (Common Elements Treatment Approach) | Experimental | Behavioral: CETA, Other: Short Message Service (SMS) text remindersParticipants 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 | Other: Short Message Service (SMS) text remindersParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult HIV positive women
- Initiated HIV treatment
- Most recent viral load >50 copies/mL or they have defaulted from treatment or had a missed or late (>14 days) visit in the last year
- Has experienced IPV in the past 12 months
- Has their own phone and can receive text messages
Key exclusion criteria (4 listed)
- Unwilling to complete the informed consent process
- Currently psychotic or on unstable psychiatric regimen
- Suicide attempt/ideation with intent and plan, and/or self-harm in the past month
- Enrolled in any other HIV treatment intervention study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CETACETA 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. | Behavioural | CETA (Common Elements Treatment Approach) |
| Short Message Service (SMS) text remindersShort Message Service (SMS) text reminders for upcoming appointments will be sent monthly. | Other | Active control, CETA (Common Elements Treatment Approach) |
Primary outcome
12 Month Viral Suppression
Time frame: 12 months post randomization
The proportion of participants who are virally suppressed (<50 copies/mL) by 12 months post randomization
10 secondary outcomes
3 Month Viral Suppression
Time frame: 3 months post randomization
12 Month Attrition Rate
Time frame: 12 months post randomization
Violence Against Women at 3 Months
Time frame: 3 months
Violence Against Women at 12 Months
Time frame: 12 months
Substance Use at 3 Months
Time frame: 3 months
Substance Use at 12 Months
Time frame: 12 months
Post-traumatic Stress Disorder (PTSD) Symptoms at 3 Months
Time frame: 3 months
Post-traumatic Stress Disorder (PTSD) Symptoms at 12 Months
Time frame: 12 months
Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 3 Months
Time frame: 3 months
Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41592903Zheng 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.
- Derived from this study: PubMed 41282709Zheng 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.
- Derived from this study: PubMed 36549749Pascoe 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Fox, DSc principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CETA and Short Message Service (SMS) text reminders in people with HIV/AIDS and Violence, run by Boston University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 Month Viral Suppression (time frame: 12 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242992, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.