HIVNCT04791865
Pediatric HIV Disclosure Benefits Study (PhD-BS) - Sankofa 2
A study testing Disclosure intervention in people with HIV, run by Boston University at 1 site in Ghana.
Trial summary
The purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- HIV
- What is being tested?
- Disclosure intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 748 participants
- Where
- 1 siteGhana
- Study dates
- 15 Jun 2021to 31 Dec 2025
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV infected children
- Children between the ages of 7-18 who do not know their HIV diagnosis (based on caregiver account and medical records confirmation) and their caregivers will be eligible to participate in the study
Who cannot join
- HIV-infected children less than 7 years
- HIV-infected children with congenital or developmental disorders
- HIV-infected children with comorbidities such as sickle cell disease or diabetes that require frequent clinic visits or hospitalizations
- Children with AIDS-defining illness or end stage AIDS.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure.
Read the detailed description
In this 5-year study, the investigators would like to build upon the successful Sankofa trial by testing the intervention in a larger scale study delivered in "real-world" clinic conditions over time in Ghana.
The purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure. The study will recruit dyads of 720 children (ages 7-18) and their caregivers from twelve (12) clinics, which will be randomly assigned to each of the four roll-out schedules ("wedge steps"), with three clinics per step.
The two groups in the study are usual care and disclosure intervention. During the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated. No formal pediatric disclosure guidelines or educational materials exist in Ghana.
During the intervention period, the manualized, with standard operation procedures, Sankofa intervention will be delivered. The intervention is guided by the disclosure model and contains key elements to target well-documented, modifiable barriers to promote disclosure.
The primary outcome is disclosure after one year (48 weeks) of the intervention. Secondary outcomes are antiretroviral medication adherence, health (virologic, immunologic, psychosocial, behavioral), cost, and implementation.
The trial will be conducted with a strong team of interdisciplinary investigators at two universities in Ghana, Yale and Johns Hopkins University in partnership with the Ghana Ministry of Health (MoH), Ghana Health Service (GHS) and a community advisory board.
- Conditions
- HIV
- Being tested
- Disclosure intervention, Usual Care
- Keywords
- resources limited settings, HIV infected children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disclosure interventionBehavioural
Participants who are assigned to the Sankofa intervention will take part in the process of disclosure (pre-disclosure, disclosure, and post-disclosure phases) with the adherence and disclosure specialist (ADDS).
Usual CareBehavioural
During the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | During the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated. Receives: Behavioral: Usual Care |
| Disclosure intervention | Experimental | Participants who are assigned to the Sankofa intervention will take part in the process of disclosure (pre-disclosure, disclosure, and post-disclosure phases) with the adherence and disclosure specialist (ADDS). Receives: Behavioral: Disclosure intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV disclosure rate
Structured and caregiver-centered and culturally-relevant disclosure intervention will be delivered by an adherence and disclosure specialist to the caregiver. After one year, the rate of disclosure of the HIV status of the children will be assessed.
Measured: 1 year after intervention
Secondary outcomes (12)
Change in Antiretroviral medication adherence
Medication adherence will be assessed with the AIDS Clinical Trials Group (ACTG) Adherence Questionnaire self-report questionnaire. This will be assessed every 3 months up until end of study. This measures provides a ratio of adherence to antiviral medication requirements. A score of 1 equals perfect adherence and 0 represents no adherence.
Measured: 5 year
Antiretroviral medication adherence - Pharmacy refill measurement
The pharmacy-based time-to-refill measure adherence is calculated as the number of months for which antiretroviral therapy claims were submitted to the pharmacy, divided by the number of complete months during the period under consideration, and the results multiplied by 100
Measured: 5 year
Antiretroviral medication adherence - HIV-1 RNA
HIV-1 RNA is calculated by
Measured: 5 year
Immunologic health
The immunologic staging of their disease according to both the U.S. CDC and WHO classification criteria will be used to determine immunologic health using patient's medical chart.
Measured: 5 year
Behavioral health - CBCL child version
Children health will be measured by using the Child Behavior checklist-child version (CBCL). For each item on the CBCL, the respondent is asked to choose from a three-point response scale indicating whether a problem behavioral description is "not true" (= 0), "somewhat or sometimes true" (= 1), or "very true or often true" (= 2) of the child
Measured: 5 year
Behavioral health - CBCL parent version
Children health will be measured by using the Child Behavior checklist-child version (CBCL). For each item on the CBCL, the respondent is asked to choose from a three-point response scale indicating whether a problem behavioral description is "not true" (= 0), "somewhat or sometimes true" (= 1), or "very true or often true" (= 2) of the child
Measured: 5 year
Child Depression Inventory (CDI)
The CDI is an 27 item questionnaire on a three-point scale to assess depression symptoms. The cumulative score will be calculated
Measured: 5 year
Beck Depression Inventory
The Caregiver's psychosocial health will be measured with the 21-item Beck Depression Inventory (BDI). The Beck Depression Inventory (BDI) is a 21-item, multiple-choice inventory. Respondents are asked to rate each item based on four response choices according to the severity of the symptoms, ranging from the absence of a symptom to an intense level, during the past week. BDI scores from 0 through 9 indicate no or minimal depression; scores from 10 through 18 indicate mild to moderate depression; scores from 19 through 29 indicate moderate to severe depression; and scores from 30 through 63 indicate severe depression.
Measured: 5 year
Implementation - Retention
Proportion of subjects retained throughout the implementation phase. This will be reported >90%, 60-90%, and <60%)
Measured: 5 year
Implementation - Caregiver 6-month log
The caregivers' 6-month surveys (e.g., caregivers' experience summarized into 3 categories: 1=Not Satisfactory, 2=Satisfactory, 3=Very Satisfactory). will be used to characterize a composite outcome for implementation success: 1= successful, 2= intermediate, 3= problematic
Measured: 6 month
Incremental cost-effectiveness ratio
The incremental cost effectiveness ratio (ICER) will be used to compare pediatric intervention relative to the standard of care to assess cost-effectiveness. The 1 year ratio will provide directly observed near term economic impact of disclosure.
Measured: 5 year
Change in HIV -1 RNA Viral Load
The HIV-1 RNA viral load will be measured every 6 months to determine the change over 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start15 Jun 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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 HIVStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Elijah Paintsil, MD, FAAP, Principal investigator, Boston University Chobanian & Avedisian School of Medicine, PediatricsVeronika Shabanova, PhD, Principal investigator, Yale University, Pediatrics, Biostatistician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791865
- Sponsor's protocol ID
- H-44300
- Other IDs
- 1R01HD103512-01
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2021
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Afrane AKA, Bobbala A, Martyn-Dickens C, Renner L, Antwi S, Kusah JT, Amissah K, Quaye D, Bosomtwe D, Gan G, Parziale S, Reynolds NR, Paintsil E, Shabanova V; Sankofa Study Team. Changes in caregiver psychosocial factors known to affect pediatric HIV disclosure: the Sankofa clinical trial experience in Ghana (2013-2023). AIDS Care. 2026 Jun;38(6):1368-1383. doi: 10.1080/09540121.2025.2594607. Epub 2025 Dec 2.
PubMed 41330401Reynolds NR, Shabanova V, Renner L, Antwi S, Ayisi Addo S, Enimil AK, Lartey M, Gan G, Parziale S, Aikins Amissah K, Kusah JT, Ofori-Atta AL, Slade E, Agyarko-Poku T, Paintsil E. Scale-up of a paediatric HIV disclosure intervention in Ghana using a stepped wedge cluster randomised trial design: Sankofa 2 protocol and implementation. BMJ Open. 2025 Nov 13;15(11):e099681. doi: 10.1136/bmjopen-2025-099681.
PubMed 41238360
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric HIV Disclosure Benefits Study (PhD-BS) - Sankofa 2
- ClinicalTrials.gov ID
- NCT04791865
- Acronym / sponsor ID
- H-44300
- Conditions
- HIV
- Keywords
- resources limited settings, HIV infected children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Mar 2021 (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 purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure.
Detailed description
In this 5-year study, the investigators would like to build upon the successful Sankofa trial by testing the intervention in a larger scale study delivered in "real-world" clinic conditions over time in Ghana.
The purpose of this study is to conduct a pragmatic, stepped wedge cluster randomized trial in 12 HIV pediatric clinics in Ghana to determine effectiveness, health benefits, cost and implementation to inform scale-up and sustainability of pediatric disclosure. The study will recruit dyads of 720 children (ages 7-18) and their caregivers from twelve (12) clinics, which will be randomly assigned to each of the four roll-out schedules ("wedge steps"), with three clinics per step.
The two groups in the study are usual care and disclosure intervention. During the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated. No formal pediatric disclosure guidelines or educational materials exist in Ghana.
During the intervention period, the manualized, with standard operation procedures, Sankofa intervention will be delivered. The intervention is guided by the disclosure model and contains key elements to target well-documented, modifiable barriers to promote disclosure.
The primary outcome is disclosure after one year (48 weeks) of the intervention. Secondary outcomes are antiretroviral medication adherence, health (virologic, immunologic, psychosocial, behavioral), cost, and implementation.
The trial will be conducted with a strong team of interdisciplinary investigators at two universities in Ghana, Yale and Johns Hopkins University in partnership with the Ghana Ministry of Health (MoH), Ghana Health Service (GHS) and a community advisory board.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareDuring the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated. |
| Disclosure intervention | Experimental | Behavioral: Disclosure interventionParticipants who are assigned to the Sankofa intervention will take part in the process of disclosure (pre-disclosure, disclosure, and post-disclosure phases) with the adherence and disclosure specialist (ADDS). |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- HIV infected children
- Children between the ages of 7-18 who do not know their HIV diagnosis (based on caregiver account and medical records confirmation) and their caregivers will be eligible to participate in the study
Key exclusion criteria (4 listed)
- HIV-infected children less than 7 years
- HIV-infected children with congenital or developmental disorders
- HIV-infected children with comorbidities such as sickle cell disease or diabetes that require frequent clinic visits or hospitalizations
- Children with AIDS-defining illness or end stage AIDS.
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 |
|---|---|---|
| Disclosure interventionParticipants who are assigned to the Sankofa intervention will take part in the process of disclosure (pre-disclosure, disclosure, and post-disclosure phases) with the adherence and disclosure specialist (ADDS). | Behavioural | Disclosure intervention |
| Usual CareDuring the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated. | Behavioural | Usual Care |
Primary outcome
HIV disclosure rate
Time frame: 1 year after intervention
Structured and caregiver-centered and culturally-relevant disclosure intervention will be delivered by an adherence and disclosure specialist to the caregiver. After one year, the rate of disclosure of the HIV status of the children will be assessed.
12 secondary outcomes
Change in Antiretroviral medication adherence
Time frame: 5 year
Antiretroviral medication adherence - Pharmacy refill measurement
Time frame: 5 year
Antiretroviral medication adherence - HIV-1 RNA
Time frame: 5 year
Immunologic health
Time frame: 5 year
Behavioral health - CBCL child version
Time frame: 5 year
Behavioral health - CBCL parent version
Time frame: 5 year
Child Depression Inventory (CDI)
Time frame: 5 year
Beck Depression Inventory
Time frame: 5 year
Implementation - Retention
Time frame: 5 year
Implementation - Caregiver 6-month log
Time frame: 6 month
Incremental cost-effectiveness ratio
Time frame: 5 year
Change in HIV -1 RNA Viral Load
Time frame: 5 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 9 Jul 2026.
- Derived from this study: PubMed 41330401Afrane AKA, Bobbala A, Martyn-Dickens C, Renner L, Antwi S, Kusah JT, Amissah K, Quaye D, Bosomtwe D, Gan G, Parziale S, Reynolds NR, Paintsil E, Shabanova V; Sankofa Study Team. Changes in caregiver psychosocial factors known to affect pediatric HIV disclosure: the Sankofa clinical trial experience in Ghana (2013-2023). AIDS Care. 2026 Jun;38(6):1368-1383. doi: 10.1080/09540121.2025.2594607. Epub 2025 Dec 2.
- Derived from this study: PubMed 41238360Reynolds NR, Shabanova V, Renner L, Antwi S, Ayisi Addo S, Enimil AK, Lartey M, Gan G, Parziale S, Aikins Amissah K, Kusah JT, Ofori-Atta AL, Slade E, Agyarko-Poku T, Paintsil E. Scale-up of a paediatric HIV disclosure intervention in Ghana using a stepped wedge cluster randomised trial design: Sankofa 2 protocol and implementation. BMJ Open. 2025 Nov 13;15(11):e099681. doi: 10.1136/bmjopen-2025-099681.
- Individual participant dataSharing planned: Yes
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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.
Elijah Paintsil, MD, FAAP principal investigator
Boston University Chobanian & Avedisian School of Medicine, Pediatrics
Veronika Shabanova, PhD principal investigator
Yale University, Pediatrics, Biostatistician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disclosure intervention in people with HIV, run by Boston University at 1 site in Ghana.
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 4 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 9 Jul 2026. 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 Ghana. 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?
HIV disclosure rate (time frame: 1 year after intervention). 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 NCT04791865, 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 9 Jul 2026.