HIVNCT04930367
CombinADO: Evaluation of an Intervention Aimed At Improving HIV Outcomes Among Adolescents and Young Adults Living with HIV in Mozambique
A study testing Radio Ads, Community Sensitization Campaign and Informational Posters in people with HIV, run by Columbia University at 12 sites in Mozambique.
Trial summary
This is a cluster-randomized trial designed to compare the effectiveness of the CombinADO strategy versus optimized standard of care (SOC) on viral suppression, antiretroviral therapy (ART) adherence and retention in HIV care among adolescents living with HIV (ALHIV) ages 10 to 24 years attending participating health… Read more about this study
- Who is it for?
- Ages 10 to 24 years
- Conditions the study is for
- HIV
- What is being tested?
- Radio Ads, Community Sensitization Campaign and Informational Posters
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,715 participants
- Where
- 12 sitesMozambique
- Study dates
- 13 Sep 2021to 4 Aug 2023
- 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 10 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV-positive, per medical records and confirmed by health facility staff
- Age 10 to 24 years
- Registered as a patient at study site
- Aware of HIV+ status
- Provision of signed and dated informed consent form
- For adolescents under 18 years of age, informed assent and parental informed consent to participate in the study
Show all 15Show fewer
- Stated willingness to comply with all study procedures
- Age 18 years and older
- Attending a caregiver-specific support group
- Willingness to be audio-recorded
- Healthcare Workers (HCW) and Key Informants (KI):
- Age 18 years and older
- Involved in the provision, management, or oversight of adolescent-focused HIV services at the 12 specified study sites
- Willingness to be audio-recorded
- For all study participants (AYAHIV, caregivers, HCW and KI):
Who cannot join
- 1. Has an acute medical condition requiring immediate medical care
- Caregivers of AYAHIV:
- Any other condition, including but not limited to alcohol or substance abuse and uncontrolled medical condition and/or allergies, that, in the opinion of the study team, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Mozambique12 sites
Cs 1 de Maio
Nampula
Cs 25 Setembro
Nampula
Cs Alua
Nampula
Cs Anexo Psi
Nampula
Cs Malema
Nampula
Cs Muhala Expansao
Nampula
Cs n1 Nacala Porto
Nampula
Cs Nametil
Nampula
Cs Namialo
Nampula
Cs Namicopo
Nampula
HG Marere
Nampula
HR Angoche
Nampula
About this study
Official title: CombinADO: a Cluster-randomized Controlled Trial to Compare the Efficacy, Uptake, Feasibility and Acceptability of the CombinADO Strategy Versus Optimized Standard of Care on Viral Suppression, ART Adherence and Retention in HIV Care Among Adolescents and Young Adults Living with HIV Ages 10-24yrs in Nampula Province, Mozambique
This is a cluster-randomized trial designed to compare the effectiveness of the CombinADO strategy versus optimized standard of care (SOC) on viral suppression, antiretroviral therapy (ART) adherence and retention in HIV care among adolescents living with HIV (ALHIV) ages 10 to 24 years attending participating health facilities. Clinics are the units of intervention allocation and randomization. The control condition will be implemented at all facilities (n=12) participating in the trial. The enhanced intervention condition will be superadded to this at a randomly selected half (n=6) of facilities. The goal of this study is to learn whether an enhanced, tailored intervention helps AYAHIV do better with their HIV care (take their medications, stay in care) than the usual care that they receive.
Read the detailed description
HIV burden among adolescents and young people worldwide is substantial, with an estimated 1.7 million adolescents aged 10-19 years living with HIV in 2019, and 460,000 adolescents aged 15-24 newly infected reported in the same year. Adolescent girls continue to be disproportionately affected, accounting for 56% of new infections worldwide. With increased availability of antiretroviral therapy (ART), pediatric mortality has decreased and healthcare workers (HCW) are now challenged to meet the complex needs of the large number of surviving youth who must cope with HIV as a chronic, highly stigmatized, and transmittable illness. There are 1.8 billion people between ages 10 and 24 and it is projected that the number of people <20 years will double by 2030. In sub-Saharan Africa (SSA), youth aged 10-24 years comprise 30-35% of the countries' population. Failure to prevent new HIV infections among adolescents will result in increased numbers of adolescents and young adults living with HIV (AYAHIV) who will strain health and social service systems as they transition to adulthood.
- Conditions
- HIV
- Being tested
- Radio Ads, Community Sensitization Campaign, Informational Posters, Motivation Walls, Pill Container
- Keywords
- HIV, Adolescents, Mozambique, ART adherence, Viral suppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio AdsBehavioural
Engaging radio mini shows that address community stigma and medical literacy through busting common myths with humor and building empathy with heartfelt storytelling.
Community Sensitization CampaignBehavioural
Large-scale, infographic billboards and posters located in public areas and secondary schools to address stigma, medical literacy and promote community support for AYAHIV.
Informational PostersBehavioural
Large-scale, infographic posters located in clinic waiting areas to normalize HIV and build confidence in treatment.
Motivation WallsBehavioural
Interactive, patient-generated posters located in the consultation room where patients can post words and phrases about themselves and their futures.
Pill ContainerOther
A discreet pill container to support ART adherence.
CombinADO-specific training for healthcare workersOther
Comprehensive in-service training for healthcare workers focused on the needs of adolescents and young adults living with HIV
One Stop Shop Model of CareOther
Model of care that allows adolescents and young adults living with HIV to access a complete set of services, including HIV care, in one central location.
Treatment ToolkitOther
A guide to clinic visits and discussions on ART and viral load monitoring to help healthcare workers better communicate with patients.
Self-reflection KitOther
A simple handout for healthcare workers to help patients reflect on their ART progress and understand the concept of viral load as a measure of ART success.
Peer SupportBehavioural
Peer exposure to examples of adolescents and young adults openly living with HIV (AYAHIV) and; opportunities to share their experiences with HIV in one-on-one interactions with other AYAHIV during clinic visits.
Informational and motivational VideoBehavioural
An informational and motivational video that in simple language with engaging graphics that a) demystifies and simplifies HIV, ART, and viral load and; b) emphasizes that people can live long, healthy lives.
Support groups- caregivers of adolescents and young adults living with HIVBehavioural
A learning, support, and empowerment group for caregivers of adolescents and young adults living with HIV (AYAHIV). Through monthly gatherings, the program aims to foster confidence, and equip caregivers with strategies to support AYAHIV adherence journey.
Support groups- adolescents and young adults living with HIVBehavioural
A peer-to-peer learning, support, and empowerment group to address loss of hope and improve medical literacy. Through biweekly gatherings, the program aims to foster belonging and confidence, equipping young people and caregivers with strategies to navigate the adherence journey.
Mental health screening and linkage to adolescent-focused mental health supportBehavioural
HCWs will be trained in the use of a brief mental health screening tool focusing on depression, anxiety, and post-traumatic stress disorder. Mental health service providers at each facility will be trained and supported to provide diagnostic and mental health support to youth with positive screens who agree to further evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Standard of Care | Active comparator | To be implemented at all 12 clinic sites, includes a set of interventions aimed at optimizing the national standard of care (billboards/posters and radio shows, healthcare worker training, one-stop adolescent and youth friendly services, information/motivation walls, pill containers and tools to be used by clinic staff during clinical visits) Receives: Behavioral: Radio Ads; Behavioral: Community Sensitization Campaign; Behavioral: Informational Posters; Behavioral: Motivation Walls; Other: Pill Container; Other: CombinADO-specific training for healthcare workers; Other: One Stop Shop Model of Care; Other: Treatment Toolkit; Other: Self-reflection Kit |
| CombinADO Strategy | Experimental | To be implemented at 6 randomly selected clinic sites, includes all interventions in the "Enhanced Standard of Care" arm plus five additional intervention components, including 1) Mental health screening and linkage to adolescent-focused mental health support, 2) peer navigation support, 3) an informational video, 4) peer support groups for AYAHIV and 5) support groups for caregivers of AYAHIV Receives: Behavioral: Radio Ads; Behavioral: Community Sensitization Campaign; Behavioral: Informational Posters; Behavioral: Motivation Walls; Other: Pill Container; Other: CombinADO-specific training for healthcare workers; Other: One Stop Shop Model of Care; Other: Treatment Toolkit; Other: Self-reflection Kit; Behavioral: Peer Support; Behavioral: Informational and motivational Video; Behavioral: Support groups- caregivers of adolescents and young adults living with HIV; Behavioral: Support groups- adolescents and young adults living with HIV; Behavioral: Mental health screening and linkage to adolescent-focused mental health support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adolescents and young people living with HIV (AYAHIV) with viral suppression (Viral load <50 copies/ml)
Viral suppression among AYAHIV at intervention versus control sites
Measured: 12 months post intervention implementation
Secondary outcomes (3)
Proportion of eligible adolescents and young people living with HIV (AYAHIV) attending clinic in a 90 day window from end of intervention implementation, as assessed at 12 months post intervention.
Retention in HIV care \& treatment among AYAHIV at intervention versus control sites
Measured: 12 months post intervention implementation
Self-reported adherence measured using 3-item adherence scale (mean score)
Self-reported ART adherence among adolescents and young people living with HIV at intervention versus control sites will be measured using a three-item adherence scale. The three items include (1) an assessment of the number of days with missed ART doses in the preceding 30 days [0-30 days]; (2) a scale rating of how good a job you did taking your medicines in the preceding 30 days (never/rarely/sometimes/usually/almost always/always) and (3) a scale rating of how often you took your medicines the way you were supposed to in the preceding 30 days (very poor/poor/fair/good/very good/ excellent).
For analyses using raw scores, item responses for the three adherence items will be linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 representing perfect adherence. The mean of the three scores are then taken to get an equally weight aggregate scale score. An overall mean from the scores from all participants will be reported.
Measured: 12 months post intervention implementation
Proportion of participants with detectable antiretroviral (ARV) on dried blood spot (DBS) specimen
ART adherence among among adolescents and young people living with HIV (AYAHIV) at intervention versus control sites, ARV levels
Measured: 12 months post intervention implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start13 Sep 2021
- Primary completion4 Aug 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Parallel groups
- Model description
- A cluster-randomized trial to compare the effectiveness of the CombinADO strategy versus optimized standard of care (SOC) on viral suppression, ART adherence and retention in HIV care among AYAHIV ages 10-24yrs attending participating health facilities. Clinics are the units of intervention allocation and randomization. The control condition will be implemented at all facilities (n=12) participating in the trial. The enhanced intervention condition will be superadded to this at a randomly selected half (n=6) of facilities.
- Masking
- None (open label)
- Enrolment
- 1,715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Elaine J. Abrams, MD, Columbia University
- Investigators
- Elaine J Abrams, MD, Principal investigator, ICAP at Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930367
- Sponsor's protocol ID
- AAAT5971
- Other IDs
- 4UH3HD096926-03
- Status last verified
- Sep 2024
- First submitted
- 5 Jun 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As required by study funder, de-identified, archived data will be transmitted to and stored at NICHD's Data and Specimen Hub (DASH) for use by other researchers including those outside of the study. Permission to transmit data to DASH will be included in the informed consent signed by all study participants. This data will only be shared after the end of the study.
Publications
Mogoba P, Falcao J, Tolla T, Zerbe A, De Gusmao EP, Myer L, Abrams EJ. A qualitative evaluation of stakeholder perspectives on the implementation of HIV services within adolescent and youth-friendly services for the youth in Nampula, Mozambique. BMC Health Serv Res. 2025 Sep 30;25(1):1229. doi: 10.1186/s12913-025-13414-0.
PubMed 41029606Mogoba P, Lesosky M, Mukonda EE, Zerbe A, Falcao J, Zandamela R, Myer L, Abrams EJ. Positive attitudes toward adoption of a multi-component intervention strategy aimed at improving HIV outcomes among adolescents and young people in Nampula, Mozambique: perspectives of HIV care providers. BMC Health Serv Res. 2023 Jun 6;23(1):582. doi: 10.1186/s12913-023-09630-1.
PubMed 37280638Mogoba P, Lesosky M, Zerbe A, Falcao J, Mellins CA, Desmond C, Arnaldo C, Kapogiannis B, Myer L, Abrams EJ. The CombinADO study to assess the impact of a combination intervention strategy on viral suppression, antiretroviral therapy adherence, and retention in HIV care among adolescents and young people living with HIV: protocol for a cluster-randomized controlled trial. Trials. 2021 Dec 27;22(1):956. doi: 10.1186/s13063-021-05943-w.
PubMed 34961567
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CombinADO: a Cluster-randomized Controlled Trial to Compare the Efficacy, Uptake, Feasibility and Acceptability of the CombinADO Strategy Versus Optimized Standard of Care on Viral Suppression, ART Adherence and Retention in HIV Care Among Adolescents and Young Adults Living with HIV Ages 10-24yrs in Nampula Province, Mozambique
- ClinicalTrials.gov ID
- NCT04930367
- Acronym / sponsor ID
- AAAT5971
- Conditions
- HIV
- Keywords
- HIV, Adolescents, Mozambique, ART adherence, Viral suppression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,715 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Cape Town, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 18 Jun 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.
This is a cluster-randomized trial designed to compare the effectiveness of the CombinADO strategy versus optimized standard of care (SOC) on viral suppression, antiretroviral therapy (ART) adherence and retention in HIV care among adolescents living with HIV (ALHIV) ages 10 to 24 years attending participating health facilities. Clinics are the units of intervention allocation and randomization. The control condition will be implemented at all facilities (n=12) participating in the trial. The enhanced intervention condition will be superadded to this at a randomly selected half (n=6) of facilities. The goal of this study is to learn whether an enhanced, tailored intervention helps AYAHIV do better with their HIV care (take their medications, stay in care) than the usual care that they receive.
Detailed description
HIV burden among adolescents and young people worldwide is substantial, with an estimated 1.7 million adolescents aged 10-19 years living with HIV in 2019, and 460,000 adolescents aged 15-24 newly infected reported in the same year. Adolescent girls continue to be disproportionately affected, accounting for 56% of new infections worldwide. With increased availability of antiretroviral therapy (ART), pediatric mortality has decreased and healthcare workers (HCW) are now challenged to meet the complex needs of the large number of surviving youth who must cope with HIV as a chronic, highly stigmatized, and transmittable illness. There are 1.8 billion people between ages 10 and 24 and it is projected that the number of people <20 years will double by 2030. In sub-Saharan Africa (SSA), youth aged 10-24 years comprise 30-35% of the countries' population. Failure to prevent new HIV infections among adolescents will result in increased numbers of adolescents and young adults living with HIV (AYAHIV) who will strain health and social service systems as they transition to adulthood.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster-randomized trial to compare the effectiveness of the CombinADO strategy versus optimized standard of care (SOC) on viral suppression, ART adherence and retention in HIV care among AYAHIV ages 10-24yrs attending participating health facilities. Clinics are the units of intervention allocation and randomization. The control condition will be implemented at all facilities (n=12) participating in the trial. The enhanced intervention condition will be superadded to this at a randomly selected half (n=6) of facilities.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Standard of Care | Active comparator | Behavioral: Radio Ads, Behavioral: Community Sensitization Campaign, Behavioral: Informational Posters, Behavioral: Motivation Walls, Other: Pill Container, Other: CombinADO-specific training for healthcare workers, Other: One Stop Shop Model of Care, Other: Treatment Toolkit, Other: Self-reflection KitTo be implemented at all 12 clinic sites, includes a set of interventions aimed at optimizing the national standard of care (billboards/posters and radio shows, healthcare worker training, one-stop adolescent and youth friendly services, information/motivation walls, pill containers and tools to be used by clinic staff during clinical visits) |
| CombinADO Strategy | Experimental | Behavioral: Radio Ads, Behavioral: Community Sensitization Campaign, Behavioral: Informational Posters, Behavioral: Motivation Walls, Other: Pill Container, Other: CombinADO-specific training for healthcare workers, Other: One Stop Shop Model of Care, Other: Treatment Toolkit, Other: Self-reflection Kit, Behavioral: Peer Support, Behavioral: Informational and motivational Video, Behavioral: Support groups- caregivers of adolescents and young adults living with HIV, Behavioral: Support groups- adolescents and young adults living with HIV, Behavioral: Mental health screening and linkage to adolescent-focused mental health supportTo be implemented at 6 randomly selected clinic sites, includes all interventions in the "Enhanced Standard of Care" arm plus five additional intervention components, including 1) Mental health screening and linkage to adolescent-focused mental health support, 2) peer navigation support, 3) an informational video, 4) peer support groups for AYAHIV and 5) support groups for caregivers of AYAHIV |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- HIV-positive, per medical records and confirmed by health facility staff
- Age 10 to 24 years
- Registered as a patient at study site
- Aware of HIV+ status
- Provision of signed and dated informed consent form
Key exclusion criteria (3 listed)
- 1. Has an acute medical condition requiring immediate medical care
- Any other condition, including but not limited to alcohol or substance abuse and uncontrolled medical condition and/or allergies, that, in the opinion of the study team, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives would make the patient unsuitable for the study or unable/unwilling to comply with the study requirements.
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 |
|---|---|---|
| Radio AdsEngaging radio mini shows that address community stigma and medical literacy through busting common myths with humor and building empathy with heartfelt storytelling. | Behavioural | CombinADO Strategy, Enhanced Standard of Care |
| Community Sensitization CampaignLarge-scale, infographic billboards and posters located in public areas and secondary schools to address stigma, medical literacy and promote community support for AYAHIV. | Behavioural | CombinADO Strategy, Enhanced Standard of Care |
| Informational PostersLarge-scale, infographic posters located in clinic waiting areas to normalize HIV and build confidence in treatment. | Behavioural | CombinADO Strategy, Enhanced Standard of Care |
| Motivation WallsInteractive, patient-generated posters located in the consultation room where patients can post words and phrases about themselves and their futures. | Behavioural | CombinADO Strategy, Enhanced Standard of Care |
| Pill ContainerA discreet pill container to support ART adherence. | Other | CombinADO Strategy, Enhanced Standard of Care |
| CombinADO-specific training for healthcare workersComprehensive in-service training for healthcare workers focused on the needs of adolescents and young adults living with HIV | Other | CombinADO Strategy, Enhanced Standard of Care |
| One Stop Shop Model of CareModel of care that allows adolescents and young adults living with HIV to access a complete set of services, including HIV care, in one central location. | Other | CombinADO Strategy, Enhanced Standard of Care |
| Treatment ToolkitA guide to clinic visits and discussions on ART and viral load monitoring to help healthcare workers better communicate with patients. | Other | CombinADO Strategy, Enhanced Standard of Care |
| Self-reflection KitA simple handout for healthcare workers to help patients reflect on their ART progress and understand the concept of viral load as a measure of ART success. | Other | CombinADO Strategy, Enhanced Standard of Care |
| Peer SupportPeer exposure to examples of adolescents and young adults openly living with HIV (AYAHIV) and; opportunities to share their experiences with HIV in one-on-one interactions with other AYAHIV during clinic visits. | Behavioural | CombinADO Strategy |
| Informational and motivational VideoAn informational and motivational video that in simple language with engaging graphics that a) demystifies and simplifies HIV, ART, and viral load and; b) emphasizes that people can live long, healthy lives. | Behavioural | CombinADO Strategy |
| Support groups- caregivers of adolescents and young adults living with HIVA learning, support, and empowerment group for caregivers of adolescents and young adults living with HIV (AYAHIV). Through monthly gatherings, the program aims to foster confidence, and equip caregivers with strategies to support AYAHIV adherence journey. | Behavioural | CombinADO Strategy |
| Support groups- adolescents and young adults living with HIVA peer-to-peer learning, support, and empowerment group to address loss of hope and improve medical literacy. Through biweekly gatherings, the program aims to foster belonging and confidence, equipping young people and caregivers with strategies to navigate the adherence journey. | Behavioural | CombinADO Strategy |
| Mental health screening and linkage to adolescent-focused mental health supportHCWs will be trained in the use of a brief mental health screening tool focusing on depression, anxiety, and post-traumatic stress disorder. Mental health service providers at each facility will be trained and supported to provide diagnostic and mental health support to youth with positive screens who agree to further evaluation. | Behavioural | CombinADO Strategy |
Primary outcome
Proportion of adolescents and young people living with HIV (AYAHIV) with viral suppression (Viral load <50 copies/ml)
Time frame: 12 months post intervention implementation
Viral suppression among AYAHIV at intervention versus control sites
3 secondary outcomes
Proportion of eligible adolescents and young people living with HIV (AYAHIV) attending clinic in a 90 day window from end of intervention implementation, as assessed at 12 months post intervention.
Time frame: 12 months post intervention implementation
Self-reported adherence measured using 3-item adherence scale (mean score)
Time frame: 12 months post intervention implementation
Proportion of participants with detectable antiretroviral (ARV) on dried blood spot (DBS) specimen
Time frame: 12 months post intervention implementation
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 19 Sep 2024.
- Derived from this study: PubMed 41029606Mogoba P, Falcao J, Tolla T, Zerbe A, De Gusmao EP, Myer L, Abrams EJ. A qualitative evaluation of stakeholder perspectives on the implementation of HIV services within adolescent and youth-friendly services for the youth in Nampula, Mozambique. BMC Health Serv Res. 2025 Sep 30;25(1):1229. doi: 10.1186/s12913-025-13414-0.
- Derived from this study: PubMed 37280638Mogoba P, Lesosky M, Mukonda EE, Zerbe A, Falcao J, Zandamela R, Myer L, Abrams EJ. Positive attitudes toward adoption of a multi-component intervention strategy aimed at improving HIV outcomes among adolescents and young people in Nampula, Mozambique: perspectives of HIV care providers. BMC Health Serv Res. 2023 Jun 6;23(1):582. doi: 10.1186/s12913-023-09630-1.
- Derived from this study: PubMed 34961567Mogoba P, Lesosky M, Zerbe A, Falcao J, Mellins CA, Desmond C, Arnaldo C, Kapogiannis B, Myer L, Abrams EJ. The CombinADO study to assess the impact of a combination intervention strategy on viral suppression, antiretroviral therapy adherence, and retention in HIV care among adolescents and young people living with HIV: protocol for a cluster-randomized controlled trial. Trials. 2021 Dec 27;22(1):956. doi: 10.1186/s13063-021-05943-w.
- Individual participant dataSharing planned: Yes. As required by study funder, de-identified, archived data will be transmitted to and stored at NICHD's Data and Specimen Hub (DASH) for use by other researchers including those outside of the study. Permission to transmit data to DASH will be included in the informed consent signed by all study participants. This data will only be shared after the end of the study.
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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.
Elaine J Abrams, MD principal investigator
ICAP at Columbia University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radio Ads, Community Sensitization Campaign and Informational Posters in people with HIV, run by Columbia University at 12 sites in Mozambique.
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 15 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Mozambique. 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?
Proportion of adolescents and young people living with HIV (AYAHIV) with viral suppression (Viral load <50 copies/ml) (time frame: 12 months post intervention implementation). 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 NCT04930367, 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 19 Sep 2024.