HIVNCT07867990
The ACT-PrEP Study
A study testing POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women. in people with HIV and PrEP, run by University of California, Los Angeles.
Trial summary
AIM: To evaluate the integration of point-of-care etiological STI testing, cognitive behavioral counselling (CBC), and sexual partner engagement strategies to improve STI management, PrEP uptake and 3-month PrEP persistence among pregnant and postpartum women PRIMARY OBJECTIVE: To evaluate the effect of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, PrEP, Acceptability
- What is being tested?
- POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years;
- HIV-negative,
- minimum gestational age of 18 weeks for pregnant women, and
- eligible for PrEP as per South African guidelines.
Who cannot join
- inability to provide informed consent,
- medical contraindications to PrEP.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ACT-PrEP Study: Aetiological STI Testing (Point-of-care), Cognitive Behavioral Counselling, and Targeted Partner Engagement to Support PrEP Enrolment and Persistence in Pregnant and Postpartum Women in South Africa
AIM: To evaluate the integration of point-of-care etiological STI testing, cognitive behavioral counselling (CBC), and sexual partner engagement strategies to improve STI management, PrEP uptake and 3-month PrEP persistence among pregnant and postpartum women PRIMARY OBJECTIVE: To evaluate the effect of the intervention on 3-month PrEP persistence among pregnant and postpartum women (PPW) SECONDARY OBJECTIVE: Determine the proportion of PPW initiating PrEP Determine the prevalence of STIs among pregnant and postpartum women Determine the feasibility and acceptability of aetiological STI testing within the antenatal and postnatal clinical workflows by HCPs Determine the acceptability and uptake of HIV/STI services by partners of pregnant and postpartum women STUDY DESIGN AND POPULATION: One-site, two-arm, individually randomized controlled type-1 hybrid implementation pilot This pilot study will follow a type-1 hybrid implementation-effectiveness design to be implemented at a public sector primary healthcare centre with a high HIV/STI burden (Gugulethu Community Health Centre).
Enrollment: 120 pregnant women attending a routine care visit. Follow-up visits may fall in the post-partum period depending on age of gestation upon enrollment. Inclusion criteria include: 1) age ≥18 years; 2) HIV-negative, 3) minimum gestational age of 18 weeks for pregnant women, and 4) eligible for PrEP as per South African guidelines. Exclusion criteria include: 1) inability to provide informed consent, 2) medical contraindications to PrEP. Sexual partners of PPW will be engaged through the distribution of HIV/syphilis self-test kits, and 10 healthcare providers will participate in cognitive behavioral counselling (CBC) training and competency assessments.
- Conditions
- HIV, PrEP, Acceptability, Appropriateness, Feasibility, Implementation Science
- Being tested
- POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women., Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.Behavioural
- Study Aim and Objectives
2.1. Overall Aim
To evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-component intervention integrating POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.
2.2. Primary Objective
To evaluate the effect of the multi-component intervention on 3-month PrEP persistence among
pregnant and postpartum women. PrEP persistence will be defined as current PrEP use at the 3-month follow-up visit (measured from enrolment), with participants who do not initiate or who discontinue PrEP classified as not persistent.
2.3. Secondary Objectives
- To determine the prevalence of STIs among pregnant and postpartum women
- To determine the feasibility and acceptability of aetiological STI testing within the antenatal and postnatal clinical workflows by HCPs
● To determine the acceptability and uptake of HIV/STI services by partners of pregnant and postpartum women
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | Not described Receives: Behavioral: POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women. |
| Control Arm | Active comparator | Standard of Care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation outcomes will include feasibility, acceptability, and appropriateness of the intervention
Feasibility, acceptability, and appropriateness data tool, this is one tool that assesses the intervention using a Likert scale: 1) completely disagree, 2) disagree, 3) neutral, 4) Agree, 5) completely agree.
Measured: 1 year
3-month PrEP persistence
PrEP initiation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start2 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town
- Responsible party
- Principal investigator, Nicole Montanez, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867990
- Sponsor's protocol ID
- IRB-26-1397
- Status last verified
- May 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of IPD is planned for this Pilot Study.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT-PrEP Study: Aetiological STI Testing (Point-of-care), Cognitive Behavioral Counselling, and Targeted Partner Engagement to Support PrEP Enrolment and Persistence in Pregnant and Postpartum Women in South Africa
- ClinicalTrials.gov ID
- NCT07867990
- Acronym / sponsor ID
- IRB-26-1397
- Conditions
- HIV, PrEP, Acceptability, Appropriateness, Feasibility, Implementation Science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Cape Town
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AIM: To evaluate the integration of point-of-care etiological STI testing, cognitive behavioral counselling (CBC), and sexual partner engagement strategies to improve STI management, PrEP uptake and 3-month PrEP persistence among pregnant and postpartum women PRIMARY OBJECTIVE: To evaluate the effect of the intervention on 3-month PrEP persistence among pregnant and postpartum women (PPW) SECONDARY OBJECTIVE: Determine the proportion of PPW initiating PrEP Determine the prevalence of STIs among pregnant and postpartum women Determine the feasibility and acceptability of aetiological STI testing within the antenatal and postnatal clinical workflows by HCPs Determine the acceptability and uptake of HIV/STI services by partners of pregnant and postpartum women STUDY DESIGN AND POPULATION: One-site, two-arm, individually randomized controlled type-1 hybrid implementation pilot This pilot study will follow a type-1 hybrid implementation-effectiveness design to be implemented at a public sector primary healthcare centre with a high HIV/STI burden (Gugulethu Community Health Centre).
Enrollment: 120 pregnant women attending a routine care visit. Follow-up visits may fall in the post-partum period depending on age of gestation upon enrollment. Inclusion criteria include: 1) age ≥18 years; 2) HIV-negative, 3) minimum gestational age of 18 weeks for pregnant women, and 4) eligible for PrEP as per South African guidelines. Exclusion criteria include: 1) inability to provide informed consent, 2) medical contraindications to PrEP. Sexual partners of PPW will be engaged through the distribution of HIV/syphilis self-test kits, and 10 healthcare providers will participate in cognitive behavioral counselling (CBC) training and competency assessments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Behavioral: POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women. |
| Control Arm | Active comparator | Other: Standard of CareStandard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥18 years;
- HIV-negative,
- minimum gestational age of 18 weeks for pregnant women, and
- eligible for PrEP as per South African guidelines.
Key exclusion criteria (2 listed)
- inability to provide informed consent,
- medical contraindications to PrEP.
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 |
|---|---|---|
| POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.2. Study Aim and Objectives 2.1. Overall Aim To evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-component intervention integrating POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women. 2.2. Primary Objective To evaluate the effect of the multi-component intervention on 3-month PrEP persistence among pregnant and postpartum women. PrEP persistence will be defined as current PrEP use at the 3-month follow-up visit (measured from enrolment), with participants who do not initiate or who discontinue PrEP classified as not persistent. 2.3. Secondary Objectives * To determine the prevalence of STIs among pregnant and postpartum women * To determine the feasibility and acceptability of aetiological STI testing within the antenatal and postnatal clinical workflows by HCPs ● To determine the acceptability and uptake of HIV/STI services by partners of pregnant and postpartum women | Behavioural | Intervention Arm |
| Standard of CareStandard of Care | Other | Control Arm |
Primary outcome
Implementation outcomes will include feasibility, acceptability, and appropriateness of the intervention
Time frame: 1 year
Feasibility, acceptability, and appropriateness data tool, this is one tool that assesses the intervention using a Likert scale: 1) completely disagree, 2) disagree, 3) neutral, 4) Agree, 5) completely agree.
3-month PrEP persistence
Time frame: 1 year
PrEP initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. No sharing of IPD is planned for this Pilot Study.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women. in people with HIV and PrEP, run by University of California, Los Angeles.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole A Montañez, MSW (3108255047, nmontanez@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation outcomes will include feasibility, acceptability, and appropriateness of the intervention (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.