HivNCT04567693
Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV
A study testing Early spaced-out appointments in people with Hiv and Aids, run by Montefiore Medical Center at 1 site in Rwanda.
Trial summary
The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- What is being tested?
- Early spaced-out appointments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteRwanda
- Study dates
- 22 Oct 2020to 18 Jul 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥15 years;
- newly-diagnosed with HIV (within 6 months);
- enrolled in care at study health facility;
- initiated ART.
Who cannot join
- planning on moving away from health center/Kigali in the next 12 months;
- unable to provide informed consent;
- enrolled in care while pregnant;
- co-infected with tuberculosis;
- concurrent known mental health or substance use disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV: a Pilot Study
The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). PLWH are currently required to visit the health center monthly for ART and clinical appointments for the first 18 months on ART, after which they can attend quarterly. Reducing the time to spaced-out appointments from 18 to 6 months has the potential to reduce the burden on patients and the health system, but may lead to suboptimal treatment outcomes. To better understand the effects of early spaced-out appointments as well as the degree of viral load monitoring needed to determine stability on ART, the investigators will conduct a 3-arm pilot intervention study. The investigators will randomize participants to 1) 6-month advancement to spaced-out appointments after 1 viral load measurement; 2) 6-month advancement to spaced-out appointments after 2 viral load measurements; or 3) usual care. The investigators will compare the study arms with respect to viral suppression at 12 months after enrollment in ART care (primary outcome) and appointment/ pharmacy adherence (secondary outcome).
Read the detailed description
Most countries in sub-Saharan Africa have adopted differentiated care models for people living with HIV (PLWH), including Rwanda. Current Rwandan HIV guidelines classify newly-diagnosed PLWH as "unstable", requiring monthly visits to the health facility. Before they can advance to being "stable" patients, with spaced-out appointments that allow them to visit the health facility every three months, they must be on antiretroviral therapy (ART) for 18 months and virally suppressed on two consecutive measurements. Patients face multiple barriers to attending frequent appointments including structural issues (such as distance to the health facility, transportation cost, long waiting times) and facing stigma while traveling to and while at the health facility. Reducing the time newly-diagnosed PLWH spend in the "unstable" category could potentially decrease the burden on patients and the health facility and potentially decrease the costs of frequent appointments. The investigators therefore propose a pilot study to examine the effect of reducing the time from ART initiation to advancement to the "stable" category from 18 to 6 months. The investigators will enroll 90 patients: 30 will be randomized to 6-month advancement to spaced out appointments after 1 viral load is measured (at 5 months after enrollment in ART care) ("Early 1"); 30 will be randomized to 6-month advancement to spaced-out appointments after 2 viral loads are measured (at 3- and 5-months after enrollment in ART care) ("Early 2"); and 30 will be randomized to continue in usual care with monthly visits ("Usual care"). The investigators will compare study arms with respect to viral suppression at 12 months (primary outcome) and appointment/pharmacy adherence (secondary outcome). The investigators hypothesize that reducing the time to the "stable" category with spaced out appointments will be feasible, acceptable, not inferior to 18 months with respect to viral suppression or adherence, and will be cost-effective.
- Being tested
- Early spaced-out appointments
- Keywords
- Rwanda, Treat All, Antiretroviral therapy
- 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.
Early spaced-out appointmentsOther
Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.
| Study group | Role | What they receive |
|---|---|---|
| Early 1 | Experimental | Advance to spaced-out appointments at month 6 after a single viral load is measured. Receives: Other: Early spaced-out appointments |
| Early 2 | Experimental | Advance to spaced-out appointments at month 6 after two viral loads are measured. Receives: Other: Early spaced-out appointments |
| Usual Care | No intervention | Do not advance to spaced-out appointments during study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
Percentage of participants with suppressed viral load (less than 200 copies/ml)
Measured: Measured at 12 months after enrollment into ART care
Secondary outcomes (3)
Appointment Adherence
Proportion of participants that attended all pharmacy and clinical appointments
Measured: Measured at 12 months after enrollment into ART care
Participant Acceptability of Reduced Time to Spaced-out Appointments
The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied [1], not satisfied [2], no opinion [3], satisfied [4], very satisfied [5]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.
Measured: Measured at 12 months after enrollment into ART care
Provider Acceptability of Reduced Time to Spaced-out Appointments
Acceptability of reduced time to spaced-out appointments, as measured by the number of instances when providers overrode the study assignment. Override could only occur a maximum of one time for each participant.
Measured: Measured at 12 months after enrollment into ART care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start22 Oct 2020
- Primary completion26 Apr 2022
- Study completion18 Jul 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 (2)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Albert Einstein College of Medicine, Rwanda Military Hospital
- Responsible party
- Sponsor
- Investigators
- Jonathan Ross, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567693
- Sponsor's protocol ID
- 2020-11551
- Other IDs
- K23MH114752
- Status last verified
- Oct 2023
- First submitted
- 17 Sep 2020
- Last updated
- 25 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a pilot study, we have elected to not allow for data to be available to other researchers for secondary analyses.
Publications
Ross J, Anastos K, Hill S, Remera E, Rwibasira GN, Ingabire C, Umwiza F, Munyaneza A, Muhoza B, Zhang C, Nash D, Yotebieng M, Murenzi G. Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial. BMC Health Serv Res. 2024 Apr 30;24(1):555. doi: 10.1186/s12913-024-10950-z.
PubMed 38693537Ross J, Murenzi G, Hill S, Remera E, Ingabire C, Umwiza F, Munyaneza A, Muhoza B, Habimana DS, Mugwaneza P, Zhang C, Yotebieng M, Anastos K. Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study. BMJ Open. 2021 Apr 24;11(4):e047443. doi: 10.1136/bmjopen-2020-047443.
PubMed 33895720
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV: a Pilot Study
- ClinicalTrials.gov ID
- NCT04567693
- Acronym / sponsor ID
- 2020-11551
- Keywords
- Rwanda, Treat All, Antiretroviral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Albert Einstein College of Medicine, Rwanda Military Hospital
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Posted 25 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). PLWH are currently required to visit the health center monthly for ART and clinical appointments for the first 18 months on ART, after which they can attend quarterly. Reducing the time to spaced-out appointments from 18 to 6 months has the potential to reduce the burden on patients and the health system, but may lead to suboptimal treatment outcomes. To better understand the effects of early spaced-out appointments as well as the degree of viral load monitoring needed to determine stability on ART, the investigators will conduct a 3-arm pilot intervention study. The investigators will randomize participants to 1) 6-month advancement to spaced-out appointments after 1 viral load measurement; 2) 6-month advancement to spaced-out appointments after 2 viral load measurements; or 3) usual care. The investigators will compare the study arms with respect to viral suppression at 12 months after enrollment in ART care (primary outcome) and appointment/ pharmacy adherence (secondary outcome).
Detailed description
Most countries in sub-Saharan Africa have adopted differentiated care models for people living with HIV (PLWH), including Rwanda. Current Rwandan HIV guidelines classify newly-diagnosed PLWH as "unstable", requiring monthly visits to the health facility. Before they can advance to being "stable" patients, with spaced-out appointments that allow them to visit the health facility every three months, they must be on antiretroviral therapy (ART) for 18 months and virally suppressed on two consecutive measurements. Patients face multiple barriers to attending frequent appointments including structural issues (such as distance to the health facility, transportation cost, long waiting times) and facing stigma while traveling to and while at the health facility. Reducing the time newly-diagnosed PLWH spend in the "unstable" category could potentially decrease the burden on patients and the health facility and potentially decrease the costs of frequent appointments. The investigators therefore propose a pilot study to examine the effect of reducing the time from ART initiation to advancement to the "stable" category from 18 to 6 months. The investigators will enroll 90 patients: 30 will be randomized to 6-month advancement to spaced out appointments after 1 viral load is measured (at 5 months after enrollment in ART care) ("Early 1"); 30 will be randomized to 6-month advancement to spaced-out appointments after 2 viral loads are measured (at 3- and 5-months after enrollment in ART care) ("Early 2"); and 30 will be randomized to continue in usual care with monthly visits ("Usual care"). The investigators will compare study arms with respect to viral suppression at 12 months (primary outcome) and appointment/pharmacy adherence (secondary outcome). The investigators hypothesize that reducing the time to the "stable" category with spaced out appointments will be feasible, acceptable, not inferior to 18 months with respect to viral suppression or adherence, and will be cost-effective.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early 1 | Experimental | Other: Early spaced-out appointmentsAdvance to spaced-out appointments at month 6 after a single viral load is measured. |
| Early 2 | Experimental | Other: Early spaced-out appointmentsAdvance to spaced-out appointments at month 6 after two viral loads are measured. |
| Usual Care | No intervention | –Do not advance to spaced-out appointments during study period |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ≥15 years;
- newly-diagnosed with HIV (within 6 months);
- enrolled in care at study health facility;
- initiated ART.
Key exclusion criteria (5 listed)
- planning on moving away from health center/Kigali in the next 12 months;
- unable to provide informed consent;
- enrolled in care while pregnant;
- co-infected with tuberculosis;
- concurrent known mental health or substance use disorder.
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 |
|---|---|---|
| Early spaced-out appointmentsNewly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits. | Other | Early 1, Early 2 |
Primary outcome
Viral Suppression
Time frame: Measured at 12 months after enrollment into ART care
Percentage of participants with suppressed viral load (less than 200 copies/ml)
3 secondary outcomes
Appointment Adherence
Time frame: Measured at 12 months after enrollment into ART care
Participant Acceptability of Reduced Time to Spaced-out Appointments
Time frame: Measured at 12 months after enrollment into ART care
Provider Acceptability of Reduced Time to Spaced-out Appointments
Time frame: Measured at 12 months after enrollment into ART care
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38693537Ross J, Anastos K, Hill S, Remera E, Rwibasira GN, Ingabire C, Umwiza F, Munyaneza A, Muhoza B, Zhang C, Nash D, Yotebieng M, Murenzi G. Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial. BMC Health Serv Res. 2024 Apr 30;24(1):555. doi: 10.1186/s12913-024-10950-z.
- Derived from this study: PubMed 33895720Ross J, Murenzi G, Hill S, Remera E, Ingabire C, Umwiza F, Munyaneza A, Muhoza B, Habimana DS, Mugwaneza P, Zhang C, Yotebieng M, Anastos K. Reducing time to differentiated service delivery for newly diagnosed people living with HIV in Kigali, Rwanda: study protocol for a pilot, unblinded, randomised controlled study. BMJ Open. 2021 Apr 24;11(4):e047443. doi: 10.1136/bmjopen-2020-047443.
- Individual participant dataSharing planned: No. As this is a pilot study, we have elected to not allow for data to be available to other researchers for secondary analyses.
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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.
Jonathan Ross principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early spaced-out appointments in people with Hiv and Aids, run by Montefiore Medical Center at 1 site in Rwanda.
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 4 inclusion and 5 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 25 Oct 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 Rwanda. 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 25 Oct 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?
Viral Suppression (time frame: Measured at 12 months after enrollment into ART care). 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 NCT04567693, 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 25 Oct 2023.