HIV-1-infectionNCT04330989
An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
A study testing iNSC and Adherence supporter training in people with HIV-1-infection and Antenatal Care, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
This study is composed of two parallel, pilot randomized groups that will obtain preliminary data about the the acceptability, fidelity, and clinical outcomes associated with a multi-component adherence support strategy for HIV treatment and prevention among pregnant and breastfeeding women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection, Antenatal Care
- What is being tested?
- iNSC and Adherence supporter training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Mar 2020to 10 Feb 2022
- 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
- Documented pregnancy by urine pregnancy test or physical exam
- Documented positive HIV status
- Initiated on first-line antiretroviral therapy (ART) within the past 30 days, either for the first time or after treatment interruption of 6 months or longer (if previously started but stopped ART)
- Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
- Ability and willingness to provide informed consent
- Documented pregnancy by urine pregnancy test or physical exam
Show all 11Show fewer
- Documented negative HIV status within the past three months
- Identified factor(s) for elevated risk for HIV acquisition, such as known positive or unknown partner HIV status; report of secondary sexual partners over the past 12 months; diagnosis of sexually transmitted infection over the past 12 months; use of post-exposure prophylaxis in the past 12 months; reported use of shared injection material or equipment; and/or unspecified concern about HIV acquisition during pregnancy and breastfeeding
- Willingness to initiate and continue HIV pre-exposure prophylaxis (PrEP) over the course of study follow-up
- Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
- Ability and willingness to provide informed consent
Who cannot join
- Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel
- Other conditions that, in the judgment of the study personnel, would make participation in the study inappropriate
- Eligibility criteria for enrollment in Group 2 (HIV-negative women):
- Positive HIV test at time of screening
- Positive hepatitis B surface antigen test at time of screening
- Renal insufficiency, defined as creatinine clearance <90 mL/min, history of known renal parenchymal disease, or known single kidney at time of screening
- Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel
- Other conditions that, in the judgment of the study personnel, would make participation in the study inappropriate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: UNCPMZ 41901 - An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women: a Pilot Study
This study is composed of two parallel, pilot randomized groups that will obtain preliminary data about the the acceptability, fidelity, and clinical outcomes associated with a multi-component adherence support strategy for HIV treatment and prevention among pregnant and breastfeeding women. The study will take place in Lilongwe, Malawi.
Read the detailed description
If the anticipated gains for the prevention of mother-to-child HIV transmission (PMTCT) programs are to be realized, adherence to antiretroviral regimens will be critical. To date, however, there are few evidence-based approaches that are scalable and sustainable in busy, programmatic settings where HIV burden is high. The study seeks to implement the intervention, which includes patient-centered counseling and adherence supporter training, for both HIV-positive (for antiretroviral therapy, or ART) and HIV-negative (for pre-exposure prophylaxis, or PrEP) pregnant and breastfeeding women, thus providing a universal approach to support PMTCT programs holistically. The study will enroll pregnant women 18 years of age or older receiving antenatal care services at one of the designated study facilities. In Group 1, the study will enroll 100 HIV-positive women who started (or re-started, after a 6 months or longer treatment interruption) a first-line ART regimen within the past 30 days. In Group 2, the study will enroll 200 HIV-negative women willing to initiate and continue oral PrEP, in the form of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC), and who report factors that place them at elevated risk for HIV acquisition.
- Conditions
- HIV-1-infection, Antenatal Care
- Being tested
- iNSC and Adherence supporter training
- Keywords
- HIV Transmission, Antiretroviral Treatment, Pre-exposure Prophylaxis, Patient-centered Counseling, Adherence Supporter Training, Antenatal Care, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNSC and Adherence supporter trainingBehavioural
Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.
| Study group | Role | What they receive |
|---|---|---|
| Group 1a: iNSC and Adherence supporter training | Experimental | HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART. Receives: Behavioral: iNSC and Adherence supporter training |
| Group 1b: Standard of Care | No intervention | HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| Group 2a: iNSC and Adherence supporter training | Experimental | HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. Receives: Behavioral: iNSC and Adherence supporter training |
| Group 2b: Standard of Care | No intervention | HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only)
The primary outcome measure is retention in care with HIV viral suppression, defined as <40 copies/mL.
Measured: 6 months following study enrollment
Number of Participants Retained in Care With Functional Adherence to PrEP (Groups 2a and 2b Only)
The primary outcome is retention in care with functional adherence to PrEP as measured categorically according to plasma and intracellular tenofovir drug concentrations.
Measured: 6 months following study enrollment
Secondary outcomes (7)
Fidelity Score Indicating How Counselors Correctly Delivered Integrated Next Step Counseling by Session
Extent to which Integrated Next Step Counseling (iNSC) was delivered as intended for each counseling session, obtained by audits of recorded counseling sessions. Counseling sessions were assessed according 50 evaluable actions. Each of these could be scored 0 (not done), 1 (partially done), and 2 (done well). These were aggregated into an overall score for fidelity, with an overall score range of 0-100. Higher scores represented greater counselor adherence to the iNSC framework.
Measured: 6 months following study enrollment
Reported Level of Satisfaction by Participants for the Study Intervention
Satisfaction with overall intervention. Participants were asked: "How satisfied would you say you are with the program overall (both the iNSC and the Adherence Supporter)?" The five possible answers are shown below.
Measured: 6 months following study enrollment
Number of Participants Retained in Care With HIV Viral Suppression <1000 Copies/mL (Groups 1a and 1b Only)
The secondary outcome measure is retention in care with HIV viral suppression, defined as <1000 copies/mL.
Measured: 6 months following study enrollment
Number of Participants Retained in Care With ART Adherence >95% Over the Last 30 Days (Groups 1a and 1b Only)
The secondary outcome measure is retention in care with self-reported ART adherence >95% over the last 30 days. Participants were asked how many pills they missed in the prior 30 days and this was used to calculate percent adherence, which was then dichotomized.
Measured: 6 months following study enrollment
Number of Participants Retained in Care With >95% Adherence to PrEP Over Last 30 Days (Groups 2a and 2b Only)
The secondary outcome is retention in care with >95% adherence to PrEP over the last 30 days by participant self-report. Participants were asked how many pills they missed in the prior 30 days and this was used to calculate percent adherence, which was then dichotomized.
Measured: 6 months following study enrollment
Number of Participants Reporting Social Harms
Newly reported social harms during study follow-up period. At each study visit, participants were asked if they had encountered any social harms related to study participation. These were documented and, where appropriate, referrals to social services were made.
Measured: 3 months following study enrollment
Number of Participants Reporting Social Harms
Newly reported social harms during study follow-up period. At each study visit, participants were asked if they had encountered any social harms related to study participation. These were documented and, where appropriate, referrals to social services were made.
Measured: 6 months following study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Mar 2020
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
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-1-infectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel pilot randomized trial in which participants randomly assigned to the control arm will receive antiretroviral adherence support about HIV treatment and prevention. Those randomized to the intervention arm will additionally receive a multi-component support strategy comprising integrated next-step counseling (iNSC) and adherence supporter training.
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Chi, MD, MSc, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330989
- Sponsor's protocol ID
- 19-1060
- Other IDs
- R01AI131060, UNCPMZ 41901
- Status last verified
- Jan 2022
- First submitted
- 30 Mar 2020
- Last updated
- 11 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mutale W, Graybill LA, Saidi F, Phanga T, Amico KR, Freeborn K, Rosenberg NE, Hill LM, Hamoonga T, Richardson BD, Mollan KR, Chi BH. Evaluation of a combination adherence strategy to support HIV antiretroviral therapy for pregnancy and breastfeeding in Malawi: A pilot randomized clinical trial. PLoS One. 2025 Apr 28;20(4):e0319735. doi: 10.1371/journal.pone.0319735. eCollection 2025.
PubMed 40293995Chi BH, Saidi F, Graybill LA, Phanga T, Mollan KR, Amico KR, Freeborn K, Rosenberg NE, Hill LM, Hamoonga T, Richardson B, Kalua T, Phiri S, Mutale W. A Patient-Centered, Combination Intervention to Support Adherence to HIV Pre-exposure Prophylaxis During Pregnancy and Breastfeeding: A Randomized Pilot Study in Malawi. J Acquir Immune Defic Syndr. 2024 Jan 1;95(1):42-51. doi: 10.1097/QAI.0000000000003309.
PubMed 37757844Saidi F, Mutale W, Freeborn K, Rosenberg NE, Graybill LA, Maman S, Amico KR, Mollan KR, Phanga T, Milala B, Hill LM, Gottwalt AM, Phiri S, Kalua T, Chi BH. Combination adherence strategy to support HIV antiretroviral therapy and pre-exposure prophylaxis adherence during pregnancy and breastfeeding: protocol for a pair of pilot randomised trials. BMJ Open. 2021 Jun 30;11(6):e046032. doi: 10.1136/bmjopen-2020-046032.
PubMed 34193491
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNCPMZ 41901 - An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women: a Pilot Study
- ClinicalTrials.gov ID
- NCT04330989
- Acronym / sponsor ID
- 19-1060
- Conditions
- HIV-1-infection, Antenatal Care
- Keywords
- HIV Transmission, Antiretroviral Treatment, Pre-exposure Prophylaxis, Patient-centered Counseling, Adherence Supporter Training, Antenatal Care, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Posted 9 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is composed of two parallel, pilot randomized groups that will obtain preliminary data about the the acceptability, fidelity, and clinical outcomes associated with a multi-component adherence support strategy for HIV treatment and prevention among pregnant and breastfeeding women. The study will take place in Lilongwe, Malawi.
Detailed description
If the anticipated gains for the prevention of mother-to-child HIV transmission (PMTCT) programs are to be realized, adherence to antiretroviral regimens will be critical. To date, however, there are few evidence-based approaches that are scalable and sustainable in busy, programmatic settings where HIV burden is high. The study seeks to implement the intervention, which includes patient-centered counseling and adherence supporter training, for both HIV-positive (for antiretroviral therapy, or ART) and HIV-negative (for pre-exposure prophylaxis, or PrEP) pregnant and breastfeeding women, thus providing a universal approach to support PMTCT programs holistically. The study will enroll pregnant women 18 years of age or older receiving antenatal care services at one of the designated study facilities. In Group 1, the study will enroll 100 HIV-positive women who started (or re-started, after a 6 months or longer treatment interruption) a first-line ART regimen within the past 30 days. In Group 2, the study will enroll 200 HIV-negative women willing to initiate and continue oral PrEP, in the form of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC), and who report factors that place them at elevated risk for HIV acquisition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a parallel pilot randomized trial in which participants randomly assigned to the control arm will receive antiretroviral adherence support about HIV treatment and prevention. Those randomized to the intervention arm will additionally receive a multi-component support strategy comprising integrated next-step counseling (iNSC) and adherence supporter training.
| Arm | Type | Receives |
|---|---|---|
| Group 1a: iNSC and Adherence supporter training | Experimental | Behavioral: iNSC and Adherence supporter trainingHIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART. |
| Group 1b: Standard of Care | No intervention | –HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm). |
| Group 2a: iNSC and Adherence supporter training | Experimental | Behavioral: iNSC and Adherence supporter trainingHIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. |
| Group 2b: Standard of Care | No intervention | –HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Documented pregnancy by urine pregnancy test or physical exam
- Documented positive HIV status
- Initiated on first-line antiretroviral therapy (ART) within the past 30 days, either for the first time or after treatment interruption of 6 months or longer (if previously started but stopped ART)
- Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
- Ability and willingness to provide informed consent
Key exclusion criteria (8 listed)
- Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel
- Other conditions that, in the judgment of the study personnel, would make participation in the study inappropriate
- Positive HIV test at time of screening
- Positive hepatitis B surface antigen test at time of screening
- Renal insufficiency, defined as creatinine clearance <90 mL/min, history of known renal parenchymal disease, or known single kidney at time of screening
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 |
|---|---|---|
| iNSC and Adherence supporter trainingIntegrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence. | Behavioural | Group 1a: iNSC and Adherence supporter training, Group 2a: iNSC and Adherence supporter training |
Primary outcome
Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only)
Time frame: 6 months following study enrollment
The primary outcome measure is retention in care with HIV viral suppression, defined as <40 copies/mL.
Number of Participants Retained in Care With Functional Adherence to PrEP (Groups 2a and 2b Only)
Time frame: 6 months following study enrollment
The primary outcome is retention in care with functional adherence to PrEP as measured categorically according to plasma and intracellular tenofovir drug concentrations.
7 secondary outcomes
Fidelity Score Indicating How Counselors Correctly Delivered Integrated Next Step Counseling by Session
Time frame: 6 months following study enrollment
Reported Level of Satisfaction by Participants for the Study Intervention
Time frame: 6 months following study enrollment
Number of Participants Retained in Care With HIV Viral Suppression <1000 Copies/mL (Groups 1a and 1b Only)
Time frame: 6 months following study enrollment
Number of Participants Retained in Care With ART Adherence >95% Over the Last 30 Days (Groups 1a and 1b Only)
Time frame: 6 months following study enrollment
Number of Participants Retained in Care With >95% Adherence to PrEP Over Last 30 Days (Groups 2a and 2b Only)
Time frame: 6 months following study enrollment
Number of Participants Reporting Social Harms
Time frame: 3 months following study enrollment
Number of Participants Reporting Social Harms
Time frame: 6 months following study enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40293995Mutale W, Graybill LA, Saidi F, Phanga T, Amico KR, Freeborn K, Rosenberg NE, Hill LM, Hamoonga T, Richardson BD, Mollan KR, Chi BH. Evaluation of a combination adherence strategy to support HIV antiretroviral therapy for pregnancy and breastfeeding in Malawi: A pilot randomized clinical trial. PLoS One. 2025 Apr 28;20(4):e0319735. doi: 10.1371/journal.pone.0319735. eCollection 2025.
- Derived from this study: PubMed 37757844Chi BH, Saidi F, Graybill LA, Phanga T, Mollan KR, Amico KR, Freeborn K, Rosenberg NE, Hill LM, Hamoonga T, Richardson B, Kalua T, Phiri S, Mutale W. A Patient-Centered, Combination Intervention to Support Adherence to HIV Pre-exposure Prophylaxis During Pregnancy and Breastfeeding: A Randomized Pilot Study in Malawi. J Acquir Immune Defic Syndr. 2024 Jan 1;95(1):42-51. doi: 10.1097/QAI.0000000000003309.
- Derived from this study: PubMed 34193491Saidi F, Mutale W, Freeborn K, Rosenberg NE, Graybill LA, Maman S, Amico KR, Mollan KR, Phanga T, Milala B, Hill LM, Gottwalt AM, Phiri S, Kalua T, Chi BH. Combination adherence strategy to support HIV antiretroviral therapy and pre-exposure prophylaxis adherence during pregnancy and breastfeeding: protocol for a pair of pilot randomised trials. BMJ Open. 2021 Jun 30;11(6):e046032. doi: 10.1136/bmjopen-2020-046032.
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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.
Benjamin Chi, MD, MSc principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iNSC and Adherence supporter training in people with HIV-1-infection and Antenatal Care, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
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 11 inclusion and 8 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 11 Jan 2023. 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 Malawi. 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 9 Jan 2023). 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?
Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only) (time frame: 6 months following study enrollment). 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 NCT04330989, 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 11 Jan 2023.