HIVENHANCED-SPSNCT04122144
Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda
A study testing ENHANCED -SPS intervention in people with HIV, run by Makerere University at 1 site in Uganda.
Trial summary
The ENHANCED -SPS study is a before and after cluster randomized trial that will be conducted in 14 public health facilities providing HIV care in Southwestern Uganda. The study will evaluate the effectiveness of a multi-component intervention package that targets barriers to achieving optimal viral suppression among… Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- ENHANCED -SPS intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- 1 siteUganda
- Study dates
- 19 Sep 2019to 19 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All Pregnant women and breastfeeding mothers enrolled in the mother baby care points/HIV clinics with documented HIV infection
- . HIV infected Pregnant women reporting for their first ANC within the study clinics or newly identified HIV positive mothers from the ANC clinics/breastfeeding
Who cannot join
- . All women who will be critically ill and unable to communicate
- . Those not willing to consent to participate in the study
- . Women who will not be able to understand all information concerning the study
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Jane Kabami
Kampala, Mbarara, +256
Jane Kabami, 0776411044, kabajane@yahoo.com
Elizabeth Arinitwe, BNSc, +256752900542, lizarinitwe10@gmail.com
About this study
Official title: Enhanced Viral Load Counseling and Standardized Peer Mother Support Study (ENHANCED-SPS)
The ENHANCED -SPS study is a before and after cluster randomized trial that will be conducted in 14 public health facilities providing HIV care in Southwestern Uganda. The study will evaluate the effectiveness of a multi-component intervention package that targets barriers to achieving optimal viral suppression among pregnant and postpartum women infected with HIV. This will be in two phases; In Phase 1 ("Before"), all 14 clinics will have a baseline assessment of standard of care VL procedures and assess the barriers and facilitators to viral suppression for a period of 3 months. In Phase 2 ("After"), 7 clinics randomized to control arm will continue to experience standard of care counseling procedures, and 7 clinics randomized to intervention will initiate the ENHANCE-PS intervention. The Phase 2 ("After") phase I will last at least 12 months.
Read the detailed description
The Investigators will test the hypothesis that the Enhanced viral load (VL) counseling and standardized peer mother support (ENHANCED-SPS) intervention will increase viral load suppression among HIV-infected pregnant and post-partum women and increase retention of mothers in care hence resulting in reduced risk of vertical transmission in south western Uganda.
Specific objectives are as follows:
- To evaluate the effectiveness of an enhanced VL counseling and standardized peer mother support intervention on viral suppression among HIV infected pregnant women at 12 months of follow up; 2) To evaluate the effect of the enhanced counseling and peer support intervention on retention in care at 18 months postpartum follow up; The investigators will randomize 14 HIV clinics to the ENHANCED-SPS multi-component intervention vs. standard of care procedures (intervention=7 clinics and control=7 clinics,n=70 mothers/health facility) ;3) To assess the facilitators and barriers of VL and enhanced VL counseling and peer mother support intervention at 9 \& 18 months of follow up.This will consider both patient and providers perspectives of the intervention implementation
- Conditions
- HIV
- Being tested
- ENHANCED -SPS intervention
- Keywords
- pregnant woman
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENHANCED -SPS interventionBehavioural
- Enhanced VL counseling: Explanation of VL \& Importance of VL suppression,assessment of adherence, counseling based on VL result and schedule for next VL testing and the role of VL and the MTCT risk; b).Standardized peer mother support: includes training of peer mothers on mandatory enhanced VL counseling during the routine peer counseling and education, follow up of mothers and continued adherence counseling and disclosure support and bi-weekly phone calls to mothers to provide VL counseling and follow up
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | ENHANCED-SPS intervention implemented Receives: Behavioral: ENHANCED -SPS intervention |
| Control | No intervention | Standard of care maintained. These are procedures conducted during the routine HIV care visits at the health facilities include ART card documentation as required, general/routine counseling, and adherence counseling to the non suppressors, ART drug supply based on the clinicians prescription and laboratory monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression
The proportion of women with HIV-1 RNA suppression at 12 months of follow up to assess the effect of the intervention
Measured: 1 year
Retention in care
The proportion of women still in care at at 12 and 18 months postpartum
Measured: 18 months
Secondary outcomes (1)
Mother to child transmission rate
The proportion of HIV free children born to the HIV positive mothers enrolled in the study at 18 months of follow up.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start19 Sep 2019
- Primary completion19 Sep 2021 (estimated)
- Study completion19 Sep 2022 (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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative effectiveness cluster-randomized trial
- Masking
- None (open label)
- Enrolment
- 980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Research Collaboration, Uganda, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Jane Kabami, MPH, Principal investigator, Makerere UniversityMoses Kamya, PhD, Principal investigator, Makerere UniversityPhillipa Musoke, PhD, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122144
- Sponsor's protocol ID
- REC REF 2018-074
- Other IDs
- HS 2648
- Acronym
- ENHANCED-SPS
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Viral Load Counseling and Standardized Peer Mother Support Study (ENHANCED-SPS)
- ClinicalTrials.gov ID
- NCT04122144
- Acronym / sponsor ID
- ENHANCED-SPS / REC REF 2018-074
- Conditions
- HIV
- Keywords
- pregnant woman
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 980 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Infectious Diseases Research Collaboration, Uganda, University of California, San Francisco
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 19 Sep 2021 (estimated)
- Study completion
- 19 Sep 2022 (estimated)
- First posted
- 10 Oct 2019 (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 ENHANCED -SPS study is a before and after cluster randomized trial that will be conducted in 14 public health facilities providing HIV care in Southwestern Uganda. The study will evaluate the effectiveness of a multi-component intervention package that targets barriers to achieving optimal viral suppression among pregnant and postpartum women infected with HIV. This will be in two phases; In Phase 1 ("Before"), all 14 clinics will have a baseline assessment of standard of care VL procedures and assess the barriers and facilitators to viral suppression for a period of 3 months. In Phase 2 ("After"), 7 clinics randomized to control arm will continue to experience standard of care counseling procedures, and 7 clinics randomized to intervention will initiate the ENHANCE-PS intervention. The Phase 2 ("After") phase I will last at least 12 months.
Detailed description
The Investigators will test the hypothesis that the Enhanced viral load (VL) counseling and standardized peer mother support (ENHANCED-SPS) intervention will increase viral load suppression among HIV-infected pregnant and post-partum women and increase retention of mothers in care hence resulting in reduced risk of vertical transmission in south western Uganda.
Specific objectives are as follows:
- To evaluate the effectiveness of an enhanced VL counseling and standardized peer mother support intervention on viral suppression among HIV infected pregnant women at 12 months of follow up; 2) To evaluate the effect of the enhanced counseling and peer support intervention on retention in care at 18 months postpartum follow up; The investigators will randomize 14 HIV clinics to the ENHANCED-SPS multi-component intervention vs. standard of care procedures (intervention=7 clinics and control=7 clinics,n=70 mothers/health facility) ;3) To assess the facilitators and barriers of VL and enhanced VL counseling and peer mother support intervention at 9 \& 18 months of follow up.This will consider both patient and providers perspectives of the intervention implementation
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative effectiveness cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ENHANCED -SPS interventionENHANCED-SPS intervention implemented |
| Control | No intervention | –Standard of care maintained. These are procedures conducted during the routine HIV care visits at the health facilities include ART card documentation as required, general/routine counseling, and adherence counseling to the non suppressors, ART drug supply based on the clinicians prescription and laboratory monitoring. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All Pregnant women and breastfeeding mothers enrolled in the mother baby care points/HIV clinics with documented HIV infection
- . HIV infected Pregnant women reporting for their first ANC within the study clinics or newly identified HIV positive mothers from the ANC clinics/breastfeeding
Key exclusion criteria (3 listed)
- . All women who will be critically ill and unable to communicate
- . Those not willing to consent to participate in the study
- . Women who will not be able to understand all information concerning the 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 |
|---|---|---|
| ENHANCED -SPS interventiona) Enhanced VL counseling: Explanation of VL \& Importance of VL suppression,assessment of adherence, counseling based on VL result and schedule for next VL testing and the role of VL and the MTCT risk; b).Standardized peer mother support: includes training of peer mothers on mandatory enhanced VL counseling during the routine peer counseling and education, follow up of mothers and continued adherence counseling and disclosure support and bi-weekly phone calls to mothers to provide VL counseling and follow up | Behavioural | Intervention |
Primary outcome
Viral suppression
Time frame: 1 year
The proportion of women with HIV-1 RNA suppression at 12 months of follow up to assess the effect of the intervention
Retention in care
Time frame: 18 months
The proportion of women still in care at at 12 and 18 months postpartum
1 secondary outcome
Mother to child transmission rate
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Jane Kabami, MPH principal investigator
Makerere University
Moses Kamya, PhD principal investigator
Makerere University
Phillipa Musoke, PhD principal investigator
Makerere 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 ENHANCED -SPS intervention in people with HIV, run by Makerere University at 1 site in Uganda.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Oct 2019. 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 Uganda. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Kabami, MPH (+256776411044, kabajane@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression (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 17 Oct 2019.