HIV(MM+)NCT06962592
Mentor Moms+ Study
A study testing MM+ in people with HIV and Alcohol Consumption, run by University of California, Los Angeles at 2 sites in South Africa.
Trial summary
The goal of this study is to adapt an existing evidence based intervention for use in pregnant and lactating people (PLP) who use alcohol. Through the pilot RCT, we aim to understand if tailored intervention, Mentor Mothers+, is effective in reducing alcohol use (primary outcome) and improving antiretroviral (PrEP or… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Alcohol Consumption
- What is being tested?
- MM+
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 1 Sep 2025to 31 Aug 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • ≥ 16 years;
- Pregnancy confirmed;
- reported alcohol use during pregnancy (in last 2 months);
- lives within 20 kilometers of the study facility;
- able and willing to consent to study participation.
Who cannot join
- Individuals not meeting the above criteria will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa2 sites, 2 recruiting
- Not yet recruiting
Saldanha Bay Municipality Clinic
Cape Town, Western Cape
Zaynab Essack, PhD, 0333245022, zessack@hsrc.ac.za
- Recruiting
Saldanha Bay Clinics
Saldanha Bay, Western Cape
Zaynab Essack Principal Investigator, PhD, +27 78 099 1509, zessack@hsrc.ac.za
About this study
Official title: A Community-based Adaptation of a Peer-led Intervention to Address Alcohol Use and HIV Risk in Pregnant Women in South Africa (Mentor Moms+)
The goal of this study is to adapt an existing evidence based intervention for use in pregnant and lactating people (PLP) who use alcohol. Through the pilot RCT, we aim to understand if tailored intervention, Mentor Mothers+, is effective in reducing alcohol use (primary outcome) and improving antiretroviral (PrEP or ART) adherence (secondary outcomes) among pregnant and breastfeeding women living with and without HIV in a community heavily burdened by this syndemic.
The investigators will conduct an pilot randomized control trial in 100 pregnant women, recruited during antenatal care (ANC) visits within the Saldanha Bay Municipality clinic in Cape Town, South Africa. The RCT will involve the delivery of brief, individual motivational interviewing sessions provided by trained mentor mothers from the community who are on either PrEP (living without HIV) or ART (living with HIV) and who stopped or reduced alcohol use during pregnancy. The enrolled participants will be followed for a 6-month period spanning both pregnancy and postpartum stages.
Read the detailed description
The syndemic of alcohol use and HIV risk in pregnant and lactating people (PLP) threatens the health of mother, fetus, children and families in South Africa. PLP living with HIV who use alcohol may access antiretroviral therapy (ART) late or disengage with ART care, increasing the risk of vertical HIV transmission. PLP not living with HIV who use alcohol are at increased risk of HIV and may require targeted interventions to receive pre-exposure prophylaxis (PrEP) delivery and adherence counselling. Alcohol use also increases risk of HIV acquisition and poor ART adherence. The "mentor mother" (MM) intervention model is an evidence-based intervention (EBI) with demonstrated success in improving HIV and antenatal care outcomes. The model utilizes a task-shifting approach; positive deviant peers (mothers) deliver interventions to PLP within and outside of the antenatal clinic.
Our study aims to evaluate the feasibility and acceptability of MM+ on reduction of alcohol use (primary outcome) and PrEP use (in PLP without HIV) and ART adherence (in PLP living with HIV) (secondary outcomes) in a pilot randomized control trial (RCT) in n=100 pregnant women who currently use alcohol. Primary outcome: Reduced alcohol use following the intervention (at 6m via phosphatidylethanol [PEth] levels). Secondary outcomes: PrEP and ART continued use at 6 months via urine tenofovir levels at 6 months.
- Conditions
- HIV, Alcohol Consumption
- Being tested
- MM+, Enhanced HIV attention control (eSOC)
- Keywords
- pregnant, postpartum, HIV prevention, HIV treatment, Alcohol use, breastfeeding
- Medical subject headings
- Alcohol Drinking, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM+Behavioural
Participants in both study arms will receive clinic-based HIV counseling, including urine tenofovir testing and biofeedback counseling on recent PrEP or ART use. Activities unique to women enrolled in the intervention arm include: Brief motivational interviewing sessions with a mentor mother focusing on 1) EtG testing and biofeedback on recent alcohol use, 2) counseling and mentorship on ways to reduce alcohol use.
Enhanced HIV attention control (eSOC)Behavioural
Participants in the enhanced HIV attention control arm (comparison group) will attend a similar number of study visits within the same time frame as intervention participants (5-6 sessions during 6-month timeframe including both pregnancy and postpartum). Control arm sessions will consist of one-on-one educational counseling on HIV risk, partner HIV testing modalities, as well as conducting PrEP/ART urine assay testing followed by real-time in-clinic adherence counseling delivered privately (different from study nurses delivering PrEP/ART biofeedback in MM+ intervention arm to avoid contamination), all coinciding with routine ANC visits.
| Study group | Role | What they receive |
|---|---|---|
| MM+ Intervention | Experimental | MM+ will involve mentor mother delivery of brief MI sessions individually over a series of clinic- based visits over a 6m period during pregnancy and postpartum. Intervention content, duration, and full menu of HIV prevention services offered will be finalized prior to launch. We anticipate no fewer than five to six 15-20 minute MI sessions focused on the benefits of reducing alcohol use during pregnancy, managing HIV risk among women without HIV and importance of ART use and viral suppression for reducing the risk of vertical transmission. Participants in MM+ arm will receive enhanced HIV prevention counseling integrated into routine antenatal care visits, including PrEP and ART biofeedback adherence counseling, provided by a trained study nurse. Participants in the intervention arm will also receive EtG testing (alcohol use) and corresponding biofeedback counseling. Receives: Behavioral: MM+ |
| Enhanced HIV attention control (eSOC) | Active comparator | Similar to placebo pills, attention control is often used in randomized trials for behavioral interventions to control for the nonspecific effects of the intervention. Given that existing MM models focus on prevention of vertical transmission and HIV treatment and our primary interest is understanding how inclusion of alcohol reduces alcohol use improves adoption of ART/PrEP use, we will use an enhanced HIV attention control with the same time frame for the intervention (e.g. 2-3 sessions during antenatal/and 2-3 sessions during postpartum periods). Sessions will consist of educational counseling on HIV risk, partner testing modalities as well as PrEP/ART urine assay testing followed by real-time in-clinic adherence counseling delivered privately by lay counselors (different from MM+ arm to avoid contamination), all coinciding with routine ANC visits when possible. Receives: Behavioral: Enhanced HIV attention control (eSOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in alcohol use (objective)
Reduced alcohol use following the intervention delivery, measured via:dried blood spot (DBS) testing of phosphatidylethanol (PEth) levels
Alcohol consumption via PEth will be defined as <20 ng/mL representing light or no consumption, >20-<200 ng/mL indicating consumption and ≥200ng/mL indicating significant or heavy recent alcohol use in past 21 days.
Measured: From enrollment to the end of intervention period at 6 months
Reduction in alcohol use (self-report)
Reduced alcohol use following the intervention delivery,measured via: self-report (AUDIT-C score).
Self-reported alcohol use (via participant survey) will be categorically defined via AUDIT-C score of 0 indicating abstinence versus score >0 indicating recent alcohol use.
Measured: From enrollment to the end of intervention period at 6 months
Secondary outcomes (5)
PrEP Initiation
Initiation to PrEP evaluated via patient medical records
Measured: From enrollment to the end of intervention period at 6 months
PrEP Adherence
Adherence to PrEP evaluated via urine tenofovir testing results
Measured: From enrollment to the end of intervention period at 6 months
ART Adherence
Adherence to ART measured via urine tenofovir (TFV) testing results. Urine TFV results will reflect recent ART adherence (past 48-72 hours).
Measured: From enrollment to the end of intervention period at 6 months
ART Adherence
Adherence to ART measured via participant self-report
Measured: From enrollment to the end of intervention period at 6 months
HIV Viral Load
HIV viral load levels will be evaluated among participants living with HIV and on ART
Measured: From enrollment to the end of intervention period at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- For the pilot RCT, we will randomize enrolled, consented participants into one of two study arms, MM+ intervention or enhanced HIV attention control, in a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, San Diego State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Dvora Joseph Davey, PhD, MPH, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962592
- Sponsor's protocol ID
- 24-0130
- Other IDs
- R34AA030942
- Acronym
- (MM+)
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will share de-identified data upon request
Publications
Essack Z, Petersen Z, Miller AP, Schoetz Dean S, Daniels D, Hofmeester H, Belin T, van Rooyen H, Louw J, Joseph Davey D. Community-Based Adaptation and Evaluation of a Peer-Led Intervention to Address Alcohol Use and HIV in Pregnant and Breastfeeding Women in South Africa: Protocol for the "Mentor Mothers Plus" Randomized Control Trial. JMIR Res Protoc. 2025 Dec 18;14:e78856. doi: 10.2196/78856.
PubMed 41411648
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Adaptation of a Peer-led Intervention to Address Alcohol Use and HIV Risk in Pregnant Women in South Africa (Mentor Moms+)
- ClinicalTrials.gov ID
- NCT06962592
- Acronym / sponsor ID
- (MM+) / 24-0130
- Conditions
- HIV, Alcohol Consumption
- Keywords
- pregnant, postpartum, HIV prevention, HIV treatment, Alcohol use, breastfeeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Cape Town, San Diego State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 8 May 2025 (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.
The goal of this study is to adapt an existing evidence based intervention for use in pregnant and lactating people (PLP) who use alcohol. Through the pilot RCT, we aim to understand if tailored intervention, Mentor Mothers+, is effective in reducing alcohol use (primary outcome) and improving antiretroviral (PrEP or ART) adherence (secondary outcomes) among pregnant and breastfeeding women living with and without HIV in a community heavily burdened by this syndemic.
The investigators will conduct an pilot randomized control trial in 100 pregnant women, recruited during antenatal care (ANC) visits within the Saldanha Bay Municipality clinic in Cape Town, South Africa. The RCT will involve the delivery of brief, individual motivational interviewing sessions provided by trained mentor mothers from the community who are on either PrEP (living without HIV) or ART (living with HIV) and who stopped or reduced alcohol use during pregnancy. The enrolled participants will be followed for a 6-month period spanning both pregnancy and postpartum stages.
Detailed description
The syndemic of alcohol use and HIV risk in pregnant and lactating people (PLP) threatens the health of mother, fetus, children and families in South Africa. PLP living with HIV who use alcohol may access antiretroviral therapy (ART) late or disengage with ART care, increasing the risk of vertical HIV transmission. PLP not living with HIV who use alcohol are at increased risk of HIV and may require targeted interventions to receive pre-exposure prophylaxis (PrEP) delivery and adherence counselling. Alcohol use also increases risk of HIV acquisition and poor ART adherence. The "mentor mother" (MM) intervention model is an evidence-based intervention (EBI) with demonstrated success in improving HIV and antenatal care outcomes. The model utilizes a task-shifting approach; positive deviant peers (mothers) deliver interventions to PLP within and outside of the antenatal clinic.
Our study aims to evaluate the feasibility and acceptability of MM+ on reduction of alcohol use (primary outcome) and PrEP use (in PLP without HIV) and ART adherence (in PLP living with HIV) (secondary outcomes) in a pilot randomized control trial (RCT) in n=100 pregnant women who currently use alcohol. Primary outcome: Reduced alcohol use following the intervention (at 6m via phosphatidylethanol [PEth] levels). Secondary outcomes: PrEP and ART continued use at 6 months via urine tenofovir levels at 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- For the pilot RCT, we will randomize enrolled, consented participants into one of two study arms, MM+ intervention or enhanced HIV attention control, in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| MM+ Intervention | Experimental | Behavioral: MM+MM+ will involve mentor mother delivery of brief MI sessions individually over a series of clinic- based visits over a 6m period during pregnancy and postpartum. Intervention content, duration, and full menu of HIV prevention services offered will be finalized prior to launch. We anticipate no fewer than five to six 15-20 minute MI sessions focused on the benefits of reducing alcohol use during pregnancy, managing HIV risk among women without HIV and importance of ART use and viral suppression for reducing the risk of vertical transmission. Participants in MM+ arm will receive enhanced HIV prevention counseling integrated into routine antenatal care visits, including PrEP and ART biofeedback adherence counseling, provided by a trained study nurse. Participants in the intervention arm will also receive EtG testing (alcohol use) and corresponding biofeedback counseling. |
| Enhanced HIV attention control (eSOC) | Active comparator | Behavioral: Enhanced HIV attention control (eSOC)Similar to placebo pills, attention control is often used in randomized trials for behavioral interventions to control for the nonspecific effects of the intervention. Given that existing MM models focus on prevention of vertical transmission and HIV treatment and our primary interest is understanding how inclusion of alcohol reduces alcohol use improves adoption of ART/PrEP use, we will use an enhanced HIV attention control with the same time frame for the intervention (e.g. 2-3 sessions during antenatal/and 2-3 sessions during postpartum periods). Sessions will consist of educational counseling on HIV risk, partner testing modalities as well as PrEP/ART urine assay testing followed by real-time in-clinic adherence counseling delivered privately by lay counselors (different from MM+ arm to avoid contamination), all coinciding with routine ANC visits when possible. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- • ≥ 16 years;
Key exclusion criteria (1 listed)
- Individuals not meeting the above criteria will be excluded.
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 |
|---|---|---|
| MM+Participants in both study arms will receive clinic-based HIV counseling, including urine tenofovir testing and biofeedback counseling on recent PrEP or ART use. Activities unique to women enrolled in the intervention arm include: Brief motivational interviewing sessions with a mentor mother focusing on 1) EtG testing and biofeedback on recent alcohol use, 2) counseling and mentorship on ways to reduce alcohol use. | Behavioural | MM+ Intervention |
| Enhanced HIV attention control (eSOC)Participants in the enhanced HIV attention control arm (comparison group) will attend a similar number of study visits within the same time frame as intervention participants (5-6 sessions during 6-month timeframe including both pregnancy and postpartum). Control arm sessions will consist of one-on-one educational counseling on HIV risk, partner HIV testing modalities, as well as conducting PrEP/ART urine assay testing followed by real-time in-clinic adherence counseling delivered privately (different from study nurses delivering PrEP/ART biofeedback in MM+ intervention arm to avoid contamination), all coinciding with routine ANC visits. | Behavioural | Enhanced HIV attention control (eSOC) |
Primary outcome
Reduction in alcohol use (objective)
Time frame: From enrollment to the end of intervention period at 6 months
Reduced alcohol use following the intervention delivery, measured via:dried blood spot (DBS) testing of phosphatidylethanol (PEth) levels Alcohol consumption via PEth will be defined as <20 ng/mL representing light or no consumption, >20-<200 ng/mL indicating consumption and ≥200ng/mL indicating significant or heavy recent alcohol use in past 21 days.
Reduction in alcohol use (self-report)
Time frame: From enrollment to the end of intervention period at 6 months
Reduced alcohol use following the intervention delivery,measured via: self-report (AUDIT-C score). Self-reported alcohol use (via participant survey) will be categorically defined via AUDIT-C score of 0 indicating abstinence versus score >0 indicating recent alcohol use.
5 secondary outcomes
PrEP Initiation
Time frame: From enrollment to the end of intervention period at 6 months
PrEP Adherence
Time frame: From enrollment to the end of intervention period at 6 months
ART Adherence
Time frame: From enrollment to the end of intervention period at 6 months
ART Adherence
Time frame: From enrollment to the end of intervention period at 6 months
HIV Viral Load
Time frame: From enrollment to the end of intervention period at 6 months
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 2 Jul 2026.
- Derived from this study: PubMed 41411648Essack Z, Petersen Z, Miller AP, Schoetz Dean S, Daniels D, Hofmeester H, Belin T, van Rooyen H, Louw J, Joseph Davey D. Community-Based Adaptation and Evaluation of a Peer-Led Intervention to Address Alcohol Use and HIV in Pregnant and Breastfeeding Women in South Africa: Protocol for the "Mentor Mothers Plus" Randomized Control Trial. JMIR Res Protoc. 2025 Dec 18;14:e78856. doi: 10.2196/78856.
- Individual participant dataSharing planned: Yes. The study team will share de-identified data upon request
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MM+ in people with HIV and Alcohol Consumption, run by University of California, Los Angeles at 2 sites 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Dvora L Joseph Davey, PhD (310-701-1526, dvoradavey@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in alcohol use (objective) (time frame: From enrollment to the end of intervention period at 6 months). 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?
On the ClinicalTrials.gov record for NCT06962592, which also lists 1 linked publication.
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 2 Jul 2026.