Alcohol Consumption, HIV
Conditions
Keywords
pregnant, postpartum, HIV prevention, HIV treatment, Alcohol use, breastfeeding
Brief 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 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.
Interventions
BEHAVIORALMM+
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.
BEHAVIORALEnhanced 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.
Sponsors
University of California, Los Angeles
University of Cape Town
San Diego State University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* • ≥ 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.
Exclusion criteria
* Individuals not meeting the above criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in alcohol use (objective) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Initiation | From enrollment to the end of intervention period at 6 months | Initiation to PrEP evaluated via patient medical records |
| PrEP Adherence | From enrollment to the end of intervention period at 6 months | Adherence to PrEP evaluated via urine tenofovir testing results |
| ART Adherence | From enrollment to the end of intervention period at 6 months | Adherence to ART measured via urine tenofovir (TFV) testing results. Urine TFV results will reflect recent ART adherence (past 48-72 hours). |
| HIV Viral Load | From enrollment to the end of intervention period at 6 months | HIV viral load levels will be evaluated among participants living with HIV and on ART |
Countries
South Africa
Contacts
CONTACTDvora L Joseph Davey, PhD
Outcome results
None listed