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Health CommunicationNCT03616106

Information Visualizations to Facilitate HIV-related Patient-provider Communication (Info Viz: HIV)

A study testing Infographic intervention in people with Health Communication, run by Columbia University at 1 site in Dominican Republic.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To complete the study aims, a mixed methods study that includes a single group pretest-posttest study design will be used to pilot test the infographic intervention. In-depth interviews will be completed with a selection of participants to explore participant perceptions of HIV-related communication using… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Health Communication
What is being tested?
Infographic intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteDominican Republic
Study dates
9 Oct 2018to 9 Aug 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (≥) 18 years of age
  • Spanish-speaking
  • Living with HIV and have a detectable viral load
  • Attend Clínica de Familia La Romana
  • Plan to receive care at the same clinic for the next year

Who cannot join

  • Does not meet inclusion criteria
  • Not able to understand study procedures or provide informed consent

Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site

  • Clínica de Familia La Romana

    La Romana

Other trials in Dominican Republic

About this study

Official title: Information Visualizations to Facilitate Patient-provider Communication in HIV Care: Info Viz HIV

To complete the study aims, a mixed methods study that includes a single group pretest-posttest study design will be used to pilot test the infographic intervention. In-depth interviews will be completed with a selection of participants to explore participant perceptions of HIV-related communication using infographics. Data will be collected from participants through baseline (at enrollment) and follow up assessments (at 3-, 6-, and 9-month follow up visits). Follow up interviews will be conducted with the providers involved in the intervention to ascertain their perspectives on the clinical utility of infographics.

Read the detailed description

The Caribbean has among the highest HIV prevalence in the world. Regionally, the majority of HIV/AIDS cases are located on the island of Hispaniola, comprised of the Dominican Republic (DR) and Haiti. Due to a large international response and widespread availability of antiretroviral therapy (ART), in recent years the incidence of HIV in the DR has declined and prevalence hovers around 1% in the general population. The effective and long-term management of this condition depends on infected individuals being able to acquire ART and apply the learned information and self-management skills that lead to optimal adherence.

HIV-related disparities exist in developing countries, such as the DR, where minority groups and/or those with low socioeconomic status experience higher disease burdens and worse health outcomes than those with higher socioeconomic status. These disparities may be exacerbated when individuals are unable to understand the health information, as low health literacy has been associated with worse health outcomes, less use of healthcare services, poorer knowledge of illness, and worse self-management. The effective management of HIV requires patients to acquire, comprehend, and use large amounts of complex information, including how to manage variations in health status, medications and their side effects, nutrition and exercise needs, and healthy coping. Health care providers can help patients understand pertinent health information by offering it in targeted, culturally-, language-, and literacy-appropriate ways.

One such strategy is to use infographics to assist communication through visual representations of information. Participatory design of infographics supports presentation of information in a culturally appropriate and visually appealing format which can improve information understanding, health behaviors, attention span, and ability to recall information. It is critical to develop and test methods to improve the way health information is delivered to patients in these clinical contexts so patients, including those with low health literacy, can acquire and comprehend the information needed to improve self-management behavior and treatment outcomes.

Preliminary studies showed many persons living with HIV (PLWH) attending Clínica de Familia La Romana do not fully comprehend and use the health information they receive through current modalities. In response, culturally relevant, evidence-based infographics to improve information delivery during clinical visits were developed with a participatory design methodology (manuscript under review). The next phase of this study is to rigorously assess if using these infographics is a feasible, acceptable, and efficacious method to enhance HIV-related clinician-patient communication and lead to improved patient outcomes. Additionally, a thorough exploration into the cultural factors of patient-provider communication in the Dominican Republic that can influence infographic use for clinician-patient communication in a clinical setting is warranted.

Being tested
Infographic intervention
Keywords
Information Visualization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infographic interventionOther

    All study participants will receive health education using infographics during their regularly scheduled clinic appointments.

Study groups in NCT03616106
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants in the intervention group will receive health education using infographics (Infographic Intervention) during their regularly scheduled clinic visits.
Receives: Other: Infographic intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association Between Mean CD4 Count at Baseline and 3-month Visit

    Association between mean CD4 count at baseline and 3-month visits.

    Measured: Baseline and 3-month visit

  2. Association Between Mean CD4 Count at Baseline and 6-month Visit

    Association between mean CD4 count at baseline and 6-month visits.

    Measured: Baseline and 6-month visit

  3. Association Between Mean CD4 Count at Baseline and 9-month Visit

    Association between mean CD4 count at baseline and 9-month visits.

    Measured: Baseline and 9-month visit

  4. Association Between Mean Viral Load at Baseline and at 3-month Visits

    Test of association of mean viral load at baseline and at 3-month visits.

    Measured: Baseline and 3-months

  5. Association Between Mean Viral Load at Baseline and at 6-month Visits

    Test of association of mean viral load at baseline and at 6-month visits.

    Measured: Baseline and 6-months

  6. Association Between Mean Viral Load at Baseline and at 9-month Visits

    Test of association of mean viral load at baseline and at 9-month visits.

    Measured: Baseline and 9-months

Secondary outcomes (25)

  1. Satisfaction With Care Scale Score

    3 questions from the overall evaluation of the HIV clinic scale were administered for a total of 19 possible points on this scale. Range of possible scores is 1-19, with 19 being highest possible satisfaction with care. The breakdown of scoring by question is as follows:

    • Question 1 is a 1-7 scale with 1 being completely unsatisfied and 7 being completely satisfied
    • Question 2 is a 1-5 scale where 1 is definitely not and 5 is definitely yes
    • Question 3 is a 1-7 scale where 1 is terrible and 7 is marvelous

    Measured: Baseline, 3-, 6-, and 9-month visits

  2. Medication Adherence

    Adherence will be measured with the validated simplified medication adherence questionnaire (SMAQ)-6 scale, a 6-item questionnaire. A person is considered "non-adherent" if there is a "yes" answer for any of items 1,2,3, and 5. Additionally, if they answer that they have missed more than two doses in the past week (item 4) or if they have gone more than two days without taking their medication in the past 3 months (item 6). Therefore, participants are classified as either adherent or not adherent based on their answers to these questions. Any participant that didn't complete study visits or did not answer that question was considered "missing."

    Measured: Baseline, 3-, 6-, and 9-month visits

  3. Participant's Self-reported Health-related Quality of Life Score - Physical Functioning

    Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.

    Measured: Up to 9 months from baseline

  4. Participants' Self-reported Health Status Over Past 4 Weeks.

    General health status was assessed with one item where participants are asked to rank their health in the past four weeks as excellent, good, fair, poor, or very poor. Results are presented as the number of participants that self-rated their health in each of those categories.

    Measured: Baseline, 3-months, 6-months, and 9-months

  5. Health Literacy

    Health literacy will be assessed using the short assessment of health literacy- Spanish. Scores range from 0 - 18 and above a 15 indicates that participants are likely to have adequate health literacy. Participants are then categorized as health literate or not health literate. The final number of participants who are health literate are reported here.

    Measured: Baseline visit only

  6. Percent of Participants Who Complete an In-depth Qualitative Interview

    Participants will be invited to participate in an in-depth qualitative interview regarding their experiences. The number who participate will be reported as a percent of the total who are enrolled.

    Measured: 9 months from baseline

  7. Participant's Self-reported Health-related Quality of Life Score - Anxiety

    Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.

    Measured: Baseline, 3-, 6-, and 9-months

  8. Participant's Self-reported Health-related Quality of Life Score - Depression

    Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.

    Measured: Baseline, 3-, 6-, and 9-months

  9. Participant's Self-reported Health-related Quality of Life Score - Fatigue

    Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.

    Measured: Baseline, 3-, 6-, and 9-months

  10. Participant's Self-reported Health-related Quality of Life Score - Sleep Disturbance

    Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.

    Measured: Baseline, 3-, 6-, and 9-months

  11. Participant's Self-reported Health-related Quality of Life Score - Social Activity Participation

    Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.

    Measured: Baseline, 3-, 6-, and 9-months

  12. Participant's Self-reported Health-related Quality of Life Score - Pain Interference

    Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.

    Measured: Baseline, 3-, 6-, and 9-months

  13. Satisfaction With Provider Scale Score at Each Time Point

    4 questions from the overall evaluation of the health care provider scale were administered for a total score of 29. The range of scores is 3-29, with 29 being the highest possible satisfaction with their health care provider. The scoring breakdown by each included question is as follows:

    • Question 1 is 1- 7 points where 1 is completely dissatisfied and 7 is completely satisfied
    • Question 2 is providing an integer value of trust in care provider on a scale from 1 to 10
    • Question 3 is 1- 7 points where 1 is terrible and 7 is marvelous
    • Question 4 is 0- 5 points where 0 is definitely not and 5 is definitely yes

    Measured: Baseline, 3-, 6-, and 9-month visits

  14. Association Between Mean HIV-related Knowledge Scores at Baseline and 3-month Visits.

    14 questions pertaining to HIV-related knowledge were developed according to the information that will be included in the intervention. Participants will receive one point for each correct answer and then the scores for each question will be summed to obtain a final score. Therefore, the minimum score will be 0 and maximum score will be 14 where the scores closer to 14 indicate patients have more HIV-related knowledge.

    Measured: Baseline and 3-month visits

  15. Association Between Mean HIV-related Knowledge Scores at Baseline and 6-month Visits.

    14 questions pertaining to HIV-related knowledge were developed according to the information that will be included in the intervention. Participants will receive one point for each correct answer and then the scores for each question will be summed to obtain a final score. Therefore, the minimum score will be 0 and maximum score will be 14 where the scores closer to 14 indicate patients have more HIV-related knowledge.

    Measured: Baseline and 6-month visits

  16. Association Between Mean HIV-related Knowledge Scores at Baseline and 9-month Visits.

    14 questions pertaining to HIV-related knowledge were developed according to the information that will be included in the intervention. Participants will receive one point for each correct answer and then the scores for each question will be summed to obtain a final score. Therefore, the minimum score will be 0 and maximum score will be 14 where the scores closer to 14 indicate patients have more HIV-related knowledge.

    Measured: Baseline and 9-month visits

  17. Association of Engagement With Clinician Scale Score at Baseline and 3-months.

    The Engagement with Health Care Providers scale is a 13 item scale through which clients rate how they feel about their interactions with their providers. Answers are recorded on a 4-point scale (1=always true and 4=never true). The range of scores is between 13 and 52. Lower scores (with 13 being the lowest score) indicate more provider engagement.

    Measured: Baseline and 3-months

  18. Association of Engagement With Clinician Scale Score at Baseline and 6-months.

    The Engagement with Health Care Providers scale is a 13 item scale through which clients rate how they feel about their interactions with their providers. Answers are recorded on a 4-point scale (1=always true and 4=never true). The range of scores is between 13 and 52. Lower scores (with 13 being the lowest score) indicate more provider engagement.

    Measured: Baseline and 6-months

  19. Association of Engagement With Clinician Scale Score at Baseline and 9-months.

    The Engagement with Health Care Providers scale is a 13 item scale through which clients rate how they feel about their interactions with their providers. Answers are recorded on a 4-point scale (1=always true and 4=never true). The range of scores is between 13 and 52. Lower scores (with 13 being the lowest score) indicate more provider engagement.

    Measured: Baseline and 9-months

  20. Association Between SEMCD Scale Score at Baseline and 3-month Visits

    Self-efficacy to manage chronic disease scale (SEMCD) will be used. This is a 6-item measure where 1 is not at all confident and 10 is completely confident. The total range of scores is 1-10. Final scores are calculated as the mean of the 6 questions, where higher scores indicate higher self-efficacy.

    Measured: Baseline, 3-month visits

  21. Association Between SEMCD Scale Score at Baseline and 6-month Visits

    Self-efficacy to manage chronic disease scale (SEMCD) will be used. This is a 6-item measure where 1 is not at all confident and 10 is completely confident. The total range of scores is 1-10. Final scores are calculated as the mean of the 6 questions, where higher scores indicate higher self-efficacy.

    Measured: Baseline, 6-month visits

  22. Association Between SEMCD Scale Score at Baseline and 9-month Visits

    Self-efficacy to manage chronic disease scale (SEMCD) will be used. This is a 6-item measure where 1 is not at all confident and 10 is completely confident. The total range of scores is 1-10. Final scores are calculated as the mean of the 6 questions, where higher scores indicate higher self-efficacy.

    Measured: Baseline, 9-month visits

  23. Association Between Current Self-reported Health Status as Reported at Baseline and 3-months

    Participants are asked to rank their current health status on a scale between 0 and 100 where 0 is "death" or the worst possible health (as bad or worse than being dead) and 100 is "perfect health", or the best possible health (without HIV infection).

    Measured: Baseline, 3-months

  24. Association Between Current Self-reported Health Status as Reported at Baseline and 6-months

    Participants are asked to rank their current health status on a scale between 0 and 100 where 0 is "death" or the worst possible health (as bad or worse than being dead) and 100 is "perfect health", or the best possible health (without HIV infection).

    Measured: Baseline, 6-months

  25. Association Between Current Self-reported Health Status as Reported at Baseline and 9-months

    Participants are asked to rank their current health status on a scale between 0 and 100 where 0 is "death" or the worst possible health (as bad or worse than being dead) and 100 is "perfect health", or the best possible health (without HIV infection).

    Measured: Baseline, 9-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start9 Oct 2018
  3. Primary completion9 Aug 2019
  4. Study completion9 Aug 2019

Resources

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
Not applicable
Intervention model
Single group
Model description
This study will use a single group pretest-posttest design to evaluate if using infographics during clinic visits can lead to improved patient outcomes.
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03616106
Sponsor's protocol ID
AAAR9023
Other IDs
1K99NR017829-01A1
Status last verified
Aug 2020
First submitted
23 Jul 2018
Last updated
3 Sep 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data of individual participant data will be made available to qualified researchers seeking to replicate methods or to those working on a new study who need the evidence-base to do so in a rigorous way. All de-identified participant data will be shared with other researchers. Please note that all of this data will be in Spanish.

Publications

  • Knobel H, Alonso J, Casado JL, Collazos J, Gonzalez J, Ruiz I, Kindelan JM, Carmona A, Juega J, Ocampo A; GEEMA Study Group. Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study. AIDS. 2002 Mar 8;16(4):605-13. doi: 10.1097/00002030-200203080-00012.

    PubMed 11873004

  • Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.

    PubMed 25091546

  • Bakken S, Holzemer WL, Brown MA, Powell-Cope GM, Turner JG, Inouye J, Nokes KM, Corless IB. Relationships between perception of engagement with health care provider and demographic characteristics, health status, and adherence to therapeutic regimen in persons with HIV/AIDS. AIDS Patient Care STDS. 2000 Apr;14(4):189-97. doi: 10.1089/108729100317795.

    PubMed 10806637

  • Dang BN, Westbrook RA, Hartman CM, Giordano TP. Retaining HIV Patients in Care: The Role of Initial Patient Care Experiences. AIDS Behav. 2016 Oct;20(10):2477-2487. doi: 10.1007/s10461-016-1340-y.

    PubMed 26910339

  • Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

    PubMed 20685078

  • De Boni R, Veloso VG, Grinsztejn B. Epidemiology of HIV in Latin America and the Caribbean. Curr Opin HIV AIDS. 2014 Mar;9(2):192-8. doi: 10.1097/COH.0000000000000031.

    PubMed 24356327

  • Figueroa JP. Review of HIV in the Caribbean: significant progress and outstanding challenges. Curr HIV/AIDS Rep. 2014 Jun;11(2):158-67. doi: 10.1007/s11904-014-0199-7.

    PubMed 24623473

  • Rojas P, Malow R, Ruffin B, Rothe EM, Rosenberg R. The HIV/AIDS Epidemic in the Dominican Republic: Key Contributing Factors. J Int Assoc Physicians AIDS Care (Chic). 2011 Sep-Oct;10(5):306-15. doi: 10.1177/1545109710397770. Epub 2011 Mar 2.

    PubMed 21368008

  • Gebre Y, Forbes NM, Peters A. Review of HIV treatment progress, gaps, and challenges in the Caribbean, 2005-2015. Rev Panam Salud Publica. 2016 Dec;40(6):468-473.

    PubMed 28718497

  • Perez-Escamilla R. Acculturation, nutrition, and health disparities in Latinos. Am J Clin Nutr. 2011 May;93(5):1163S-7S. doi: 10.3945/ajcn.110.003467. Epub 2011 Mar 2.

    PubMed 21367946

  • Barreto SM, Miranda JJ, Figueroa JP, Schmidt MI, Munoz S, Kuri-Morales PP, Silva JB Jr. Epidemiology in Latin America and the Caribbean: current situation and challenges. Int J Epidemiol. 2012 Apr;41(2):557-71. doi: 10.1093/ije/dys017. Epub 2012 Mar 9.

    PubMed 22407860

  • Wawrzyniak AJ, Ownby RL, McCoy K, Waldrop-Valverde D. Health literacy: impact on the health of HIV-infected individuals. Curr HIV/AIDS Rep. 2013 Dec;10(4):295-304. doi: 10.1007/s11904-013-0178-4.

    PubMed 24222474

  • Laws MB, Lee Y, Rogers WH, Beach MC, Saha S, Korthuis PT, Sharp V, Cohn J, Moore R, Wilson IB. Provider-patient communication about adherence to anti-retroviral regimens differs by patient race and ethnicity. AIDS Behav. 2014 Jul;18(7):1279-87. doi: 10.1007/s10461-014-0697-z.

    PubMed 24464408

  • Kalichman SC, Rompa D. Functional health literacy is associated with health status and health-related knowledge in people living with HIV-AIDS. J Acquir Immune Defic Syndr. 2000 Dec 1;25(4):337-44. doi: 10.1097/00042560-200012010-00007.

    PubMed 11114834

  • Zhang NJ, Terry A, McHorney CA. Impact of health literacy on medication adherence: a systematic review and meta-analysis. Ann Pharmacother. 2014 Jun;48(6):741-51. doi: 10.1177/1060028014526562. Epub 2014 Mar 11.

    PubMed 24619949

Questions about this trial

What is this clinical trial studying?

A study testing Infographic intervention in people with Health Communication, run by Columbia University at 1 site in Dominican Republic.

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 5 inclusion and 2 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 3 Sep 2020. 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 Dominican Republic. 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 3 Sep 2020). 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?

Association Between Mean CD4 Count at Baseline and 3-month Visit (time frame: Baseline and 3-month visit). The study lists 6 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 NCT03616106, which also lists 27 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 3 Sep 2020.

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