Human Immunodeficiency VirusFLCsNCT02515370
Friends for Life Circles for Option B Plus
A study testing Friends for Life Circles (FLCs). in people with Human Immunodeficiency Virus, run by MU-JHU CARE at 1 site in Uganda.
Trial summary
The main goal of the study is to support HIV-infected pregnant women initiated on PMTCT Option B+ during antenatal to adhere to lifelong ART and postpartum care visits through an enhanced group peer support intervention called "friends for life circles". Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Friends for Life Circles (FLCs).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteUganda
- Study dates
- May 2016to Aug 2020
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age >18 years
- Documentation of pregnancy through clinical assessment or pregnancy test
- Documentation of confirmed HIV-positive sero-status at the time of screening
- Accepting to receive option B+ for PMTCT
- Providing written informed consent to participate in the randomized trial.
- Agreeing to come the study clinic for scheduled appointments
Show all 9Show fewer
- Agreeing to be home visited as needed to ensure follow up
- Residing within a 20 km radius around the study clinic
- Not planning to move out of the catchment area within the next 2 years
Who cannot join
- Social and other circumstances that may prevent the mother from coming back for follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Enhanced Peer Group Strategies to Support Prevention of Mother to Child HIV Transmission (PMTCT) Option B+ in Uganda
The main goal of the study is to support HIV-infected pregnant women initiated on PMTCT Option B+ during antenatal to adhere to lifelong ART and postpartum care visits through an enhanced group peer support intervention called "friends for life circles".
Read the detailed description
The overall goal of this implementation research is to improve retention in care and adherence to ART to 2 years postpartum among HIV infected women in urban and rural Uganda choosing PMTCT Option B+. Formative research will first be conducted to assess knowledge and attitudes regarding Option B+ and lifelong ART among PMTCT clients, community members and health workers. The formative research will inform the design of the group peer support intervention. Interventional research will then be conducted randomizing 540 women to either enhanced group peer support with income generating activities called the Friends for Life Circle (FLC) or MOH standard of care counselling with follow-up to 2 years postpartum. Primary outcomes will include retention in health care, ARV adherence and viral suppression at 6 weeks and 24 months postpartum. Secondary outcomes will include participants' health and economic outcomes.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Friends for Life Circles (FLCs).
- Keywords
- Option B plus, HIV infected women
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Friends for Life Circles (FLCs).Other
The intervention 'Friends for Life Circles" (FLCs) will build dynamic peer group support in the community aimed at supporting maternal adherence to appointment keeping and taking lifetime antiretroviral drugs
| Study group | Role | What they receive |
|---|---|---|
| Friends for Life Circles (FLC) | Experimental | The intervention will include formation of peer support groups of eight to ten women in the community with incorporation of income generating activities to improve maternal adherence to clinic appointments and life long antiretroviral therapy Receives: Other: Friends for Life Circles (FLCs). |
| Standard of Care (SOC) | No intervention | Normal standard of care and follow up. The standard care provided in the clinic will be provided for the control arem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
in care will be measured as 1 minus proportion of women lost to follow-up at 24 months postpartum
Measured: 2 years
Adherence to Option B+ ARV drugs
compare maternal antiretroviral drug adherence using self-report, viral load in blood at delivery, 6 weeks, 6 and 24 months postpartum among all HIV-infected pregnant women participating in the study.
Measured: 2 years
Secondary outcomes (2)
Infant HIV Free survival
also compare infant HIV-free survival at 6 weeks and 18 months among women randomized to the enhanced community-based intervention (FLC) versus the MOH SOC. Infants born to HIV-infected mothers are tested routinely at 6 weeks of
age for HIV DNA by PCR and at 18 months of age by rapid HIV antibody test as part of the national Early Infant HIV Diagnosis program which is standard of care in every government health unit offering postnatal care in Uganda
Measured: 2 years
Assessing success and sustainability of FLCs group support activities and IGAs
Each FLC will be assessed to see which groups were most successful in developing specific IGAs. The evaluation will be focus on the ability of FLCs to effectively generate income, participant attendance to the circles' IGA-related activities, key skills gained by participants in the circles and the percent increase or decrease in personal and household income
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startMay 2016
- Primary completionMay 2019
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies 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
- Masking
- None (open label)
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- MU-JHU CARE
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Philippa Musoke, MBChB, PhD, MU-JHU CARE
- Investigators
- Philippa Musoke, MD PhD, Principal investigator, MU-JHU CARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515370
- Sponsor's protocol ID
- Musoke-R01-080476-Option B+
- Acronym
- FLCs
- Status last verified
- Mar 2023
- First submitted
- 30 Jul 2015
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Amone A, Gabagaya G, Wavamunno P, Rukundo G, Namale-Matovu J, Malamba SS, Lubega I, Homsy J, King R, Nakabiito C, Namukwaya Z, Fowler MG, Musoke P. Enhanced peer-group strategies to support the prevention of mother-to-child HIV transmission leads to increased retention in care in Uganda: A randomized controlled trial. PLoS One. 2024 Apr 19;19(4):e0297652. doi: 10.1371/journal.pone.0297652. eCollection 2024.
PubMed 38640123Gabagaya G, Rukundo G, Amone A, Wavamunno P, Namale-Matovu J, Lubega I, Nakabiito C, Namukwaya Z, Nolan M, Malamba SS, King R, Homsy J, Fowler MG, Musoke P. Prevalence of undetectable and suppressed viral load in HIV-infected pregnant women initiating Option B+ in Uganda: an observational study nested within a randomized controlled trial. BMC Infect Dis. 2021 Sep 4;21(1):907. doi: 10.1186/s12879-021-06608-4.
PubMed 34481464
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Enhanced Peer Group Strategies to Support Prevention of Mother to Child HIV Transmission (PMTCT) Option B+ in Uganda
- ClinicalTrials.gov ID
- NCT02515370
- Acronym / sponsor ID
- FLCs / Musoke-R01-080476-Option B+
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Option B plus, HIV infected women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- MU-JHU CAREUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- May 2016
- Primary completion
- May 2019 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 4 Aug 2015 (estimated)
- 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 main goal of the study is to support HIV-infected pregnant women initiated on PMTCT Option B+ during antenatal to adhere to lifelong ART and postpartum care visits through an enhanced group peer support intervention called "friends for life circles".
Detailed description
The overall goal of this implementation research is to improve retention in care and adherence to ART to 2 years postpartum among HIV infected women in urban and rural Uganda choosing PMTCT Option B+. Formative research will first be conducted to assess knowledge and attitudes regarding Option B+ and lifelong ART among PMTCT clients, community members and health workers. The formative research will inform the design of the group peer support intervention. Interventional research will then be conducted randomizing 540 women to either enhanced group peer support with income generating activities called the Friends for Life Circle (FLC) or MOH standard of care counselling with follow-up to 2 years postpartum. Primary outcomes will include retention in health care, ARV adherence and viral suppression at 6 weeks and 24 months postpartum. Secondary outcomes will include participants' health and economic outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Friends for Life Circles (FLC) | Experimental | Other: Friends for Life Circles (FLCs).The intervention will include formation of peer support groups of eight to ten women in the community with incorporation of income generating activities to improve maternal adherence to clinic appointments and life long antiretroviral therapy |
| Standard of Care (SOC) | No intervention | –Normal standard of care and follow up. The standard care provided in the clinic will be provided for the control arem |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age >18 years
- Documentation of pregnancy through clinical assessment or pregnancy test
- Documentation of confirmed HIV-positive sero-status at the time of screening
- Accepting to receive option B+ for PMTCT
- Providing written informed consent to participate in the randomized trial.
Key exclusion criteria (1 listed)
- Social and other circumstances that may prevent the mother from coming back for follow up
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 |
|---|---|---|
| Friends for Life Circles (FLCs).The intervention 'Friends for Life Circles" (FLCs) will build dynamic peer group support in the community aimed at supporting maternal adherence to appointment keeping and taking lifetime antiretroviral drugs | Other | Friends for Life Circles (FLC) |
Primary outcome
Retention
Time frame: 2 years
in care will be measured as 1 minus proportion of women lost to follow-up at 24 months postpartum
Adherence to Option B+ ARV drugs
Time frame: 2 years
compare maternal antiretroviral drug adherence using self-report, viral load in blood at delivery, 6 weeks, 6 and 24 months postpartum among all HIV-infected pregnant women participating in the study.
2 secondary outcomes
Infant HIV Free survival
Time frame: 2 years
Assessing success and sustainability of FLCs group support activities and IGAs
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Derived from this study: PubMed 38640123Amone A, Gabagaya G, Wavamunno P, Rukundo G, Namale-Matovu J, Malamba SS, Lubega I, Homsy J, King R, Nakabiito C, Namukwaya Z, Fowler MG, Musoke P. Enhanced peer-group strategies to support the prevention of mother-to-child HIV transmission leads to increased retention in care in Uganda: A randomized controlled trial. PLoS One. 2024 Apr 19;19(4):e0297652. doi: 10.1371/journal.pone.0297652. eCollection 2024.
- Derived from this study: PubMed 34481464Gabagaya G, Rukundo G, Amone A, Wavamunno P, Namale-Matovu J, Lubega I, Nakabiito C, Namukwaya Z, Nolan M, Malamba SS, King R, Homsy J, Fowler MG, Musoke P. Prevalence of undetectable and suppressed viral load in HIV-infected pregnant women initiating Option B+ in Uganda: an observational study nested within a randomized controlled trial. BMC Infect Dis. 2021 Sep 4;21(1):907. doi: 10.1186/s12879-021-06608-4.
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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.
Philippa Musoke, MD PhD principal investigator
MU-JHU CARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Friends for Life Circles (FLCs). in people with Human Immunodeficiency Virus, run by MU-JHU CARE 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 9 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: finished, as of the sponsor's last update on 17 Mar 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retention (time frame: 2 years). 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 NCT02515370, which also lists 2 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 17 Mar 2023.