HIV PositiveNCT01152684
Complementary & Alternative Medicine Use in HIV+ Latinos in the US-Mexico Border
An observational study of HIV Positive, run by University of California, San Diego at 1 site in United States.
Trial summary
The goal of The investigators community-based participatory research study is to identify the nature and extent of complementary and alternative medicine (CAM) use among HIV-positive Latinos on the San Diego/Tijuana border. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Positive
- How many people
- 541 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population will be selected from 2 locations: 1. San Diego: San Ysidro Health Center(SYHC) will serve as the recruitment site on the US side of the border. Latinos comprise >90% of SYHC's patient population. SYHC provides HIV primary medical care to over 400 HIV-positive individuals. SYHC's HIV-positive Latino patient population includes persons who may or may not be on ARVs and who participate in clinic services to varying degrees. Previous studies with HIV-positive patients at SYHC indicate cross-border mobility and bi-national care seeking behavior in this clinic population. 2.Tijuana: The Agencia Familiar Binacional (AFABI;Binational Health Agency) opened the first HIV medical and social services agency clinic in Tijuana. This clinic is in close proximity to the municipal health clinic, where a large number of HIV-positive cases are diagnosed, and is linked with other non-profit social services agencies for HIV-positive persons, many of whom face barriers to ARVs.
Who may be able to join
- Latino
- Speak English or Spanish or both
- Lived in San Diego or Tijuana for at least 1 month in the last year
- 18 years or older
- HIV-positive or living with AIDS
Who cannot join
- Non-Latino
- Speak neither English nor Spanish
- Have not lived in San Diego or Tijuana for at least 1 month in the last year
- Under 18 years of age
- Not HIV-positive or living with AIDS
Trial locations and contacts
1 site in 1 country.
United States1 site
San Ysidro Health Center
San Ysidro, California, 92173
About this study
Official title: Complementary & Alternative Care Behavior in HIV+ Latinos in the US-Mexico Border
The goal of The investigators community-based participatory research study is to identify the nature and extent of complementary and alternative medicine (CAM) use among HIV-positive Latinos on the San Diego/Tijuana border. CAM use among US Latinos living with HIV is associated with delayed utilization of and poor adherence to antiretroviral therapies (ARVs) that may exacerbate health disparities in HIV care access and health outcomes. This study will lead to development of culturally-effective interventions to improve access and adherence to HIV care in Latinos who face health disparities. The investigators hypothesis is that greater use of CAM will be observed among HIV-positive Latinos who report a) crossing the U.S. border more frequently, and b) having migrated to Tijuana or San Diego (e.g. from southern Mexico). The investigators also hypothesize that compared to HIV-positive Latinos who report using herbal CAM, those who do not use herbal CAM are more likely to be receiving ARVs and report higher levels of adherence to ARVs; Compared to HIV-positive Latinos who do not attend religious services regularly, those who attend religious services regularly are more likely to be receiving ARV; Compared to HIV- positive Latinos who report experiencing HIV related stigma, those who do not report experiencing HIV-related stigma are significantly more likely to be receiving ARVs.
Read the detailed description
The goal of our community-based participatory research study is to identify the nature and extent of complementary and alternative medicine (CAM) use among HIV-positive Latinos on the San Diego/Tijuana border. CAM utilization among US Latinos living with HIV is associated with delayed utilization of and poor adherence to antiretroviral therapies (ARVs) that may exacerbate health disparities in HIV care access and health outcomes. US Latinos face more barriers to HIV care than non-Latino Whites including less health insurance, delays in seeking HIV care, and entering care at advanced stages of HIV disease. Latinos living with HIV/AIDS may be more likely to use CAM when faced with barriers to accessing conventional HIV care than non-Latino Whites. CAM use, including herbal therapies, seeking care from alternative healers, and religious practices may be implicated in HIV-related health disparities for US Latinos living with HIV, but research is lacking, particularly in the context of binational healthcare utilization. The United States (US)-Mexico border is a demographically booming region characterized by a shared population living on either side of the border and who cross frequently to Tijuana or to San Diego; US HIV care providers working in the USMexico border region serve many Latinos who access services and care on both sides of the border.Concern over clinician reaction to CAM may erode Latino patient-provider communication, yet assessment of CAM use from patient and clinician perspective and health system characteristics is also lacking. We will describe CAM use in HIV-positive Latinos in the US-Mexico border region to improve culturally-effective care delivery and inform future biomedical and behavioral interventions to decrease disparities in ARV access and utilization, and improve HIV-related health outcomes for US Latinos.
Specific aims of our study are:
Aim 1: To assess CAM-specific health care behavior, including bi-national CAM utilization from allied/alternative health personnel (e.g. pharmacists, non-Western medicine healers) among HIV-positive Latinos residing in Tijuana and San Diego.
Hypothesis 1 (H1) Greater use of CAM will be observed among HIV-positive Latinos who report a) crossing the U.S. border more frequently, and b) having migrated to Tijuana or San Diego (e.g. from southern Mexico).
Aim 2: To assess use of CAM in the context of HIV treatment utilization and practices, including factors related to delayed entry into HIV care (e.g. HIV stigma); and access to, utilization of and adherence to ARVs among HIV-positive Latinos residing in Tijuana or San Diego. H2.a) Compared to HIV-positive Latinos who report using herbal CAM, those who do not use herbal CAM are more likely to be using ARVs and report higher levels of adherence to ARVs; H2.b) Compared to HIV-positive Latinos who do not attend religious services regularly, those who attend religious services regularly are more likely to use ARV.
H2.c) Compared to HIV-positive Latinos who report experiencing HIV-related stigma, those who do not report experiencing HIV-related stigma are significantly more likely to use ARVs and report lesser utilization of CAM.
Aim 3: To determine perceived barriers to communicating use of CAM and ARV adherence to clinicians among HIV-positive Latinos residing in Tijuana or San Diego, including satisfaction with clinician communication; concern about physician response to reporting CAM modalities such as herbal therapies, pharmacy practices in Mexico and folk healing perception of ARV efficacy, and perception of ARV efficacy.
H3) Among HIV-positive CAM users, disclosure of CAM use will be higher in Latino patients who report higher satisfaction with communication with clinicians than those who report lower satisfaction with clinicians.
Aim 4: To explore provider and system barriers to culturally-effective communication about CAM and ARV adherence with HIV-positive Latino patients, including clinician knowledge about patient CAM practices.
To address Aims 1-3 we will conduct a quantitative study using interviewer-administered surveys with 200 HIV positive Latinos (100 from each side of the border). In Aim 4 we will purposively sample 20 HIV clinicians on both sides of the border and conduct in-depth interviews. Our aims are consistent with the Office of AIDS Research 2008 Plan to assess sociocultural and structural determinants and health systems that enhance, sustain and/or perpetuate health disparities.7 Capitalizing on our HIV research expertise with Latino communities, this study will lead to development of culturally-effective interventions to improve timeliness and adherence to HIV care in populations with documented health disparities and will reduce gaps in care.
- Conditions
- HIV Positive
- Keywords
- CAM, HIV-Positive, Latinos, US-Mexico Border region, San Diego-Tijuana, Identify the nature and extent of complementary and alternative medicine use among HIV-positive Latinos in the US-Mexico border region
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-Positive Latinos living in San Diego or Tijuana | This is an exploratory study of Latinos living with HIV in the San Diego-Tijuana US-Mexico border region. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PositiveStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Maria L Zúñiga, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152684
- Sponsor's protocol ID
- R21AT004676-01A1
- Other IDs
- R21AT004676-01A1
- Status last verified
- Feb 2020
- First submitted
- 25 Jun 2010
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary & Alternative Care Behavior in HIV+ Latinos in the US-Mexico Border
- ClinicalTrials.gov ID
- NCT01152684
- Acronym / sponsor ID
- R21AT004676-01A1
- Conditions
- HIV Positive
- Keywords
- CAM, HIV-Positive, Latinos, US-Mexico Border region, San Diego-Tijuana, Identify the nature and extent of complementary and alternative medicine use among HIV-positive Latinos in the US-Mexico border region
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2009 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of The investigators community-based participatory research study is to identify the nature and extent of complementary and alternative medicine (CAM) use among HIV-positive Latinos on the San Diego/Tijuana border. CAM use among US Latinos living with HIV is associated with delayed utilization of and poor adherence to antiretroviral therapies (ARVs) that may exacerbate health disparities in HIV care access and health outcomes. This study will lead to development of culturally-effective interventions to improve access and adherence to HIV care in Latinos who face health disparities. The investigators hypothesis is that greater use of CAM will be observed among HIV-positive Latinos who report a) crossing the U.S. border more frequently, and b) having migrated to Tijuana or San Diego (e.g. from southern Mexico). The investigators also hypothesize that compared to HIV-positive Latinos who report using herbal CAM, those who do not use herbal CAM are more likely to be receiving ARVs and report higher levels of adherence to ARVs; Compared to HIV-positive Latinos who do not attend religious services regularly, those who attend religious services regularly are more likely to be receiving ARV; Compared to HIV- positive Latinos who report experiencing HIV related stigma, those who do not report experiencing HIV-related stigma are significantly more likely to be receiving ARVs.
Detailed description
The goal of our community-based participatory research study is to identify the nature and extent of complementary and alternative medicine (CAM) use among HIV-positive Latinos on the San Diego/Tijuana border. CAM utilization among US Latinos living with HIV is associated with delayed utilization of and poor adherence to antiretroviral therapies (ARVs) that may exacerbate health disparities in HIV care access and health outcomes. US Latinos face more barriers to HIV care than non-Latino Whites including less health insurance, delays in seeking HIV care, and entering care at advanced stages of HIV disease. Latinos living with HIV/AIDS may be more likely to use CAM when faced with barriers to accessing conventional HIV care than non-Latino Whites. CAM use, including herbal therapies, seeking care from alternative healers, and religious practices may be implicated in HIV-related health disparities for US Latinos living with HIV, but research is lacking, particularly in the context of binational healthcare utilization. The United States (US)-Mexico border is a demographically booming region characterized by a shared population living on either side of the border and who cross frequently to Tijuana or to San Diego; US HIV care providers working in the USMexico border region serve many Latinos who access services and care on both sides of the border.Concern over clinician reaction to CAM may erode Latino patient-provider communication, yet assessment of CAM use from patient and clinician perspective and health system characteristics is also lacking. We will describe CAM use in HIV-positive Latinos in the US-Mexico border region to improve culturally-effective care delivery and inform future biomedical and behavioral interventions to decrease disparities in ARV access and utilization, and improve HIV-related health outcomes for US Latinos.
Specific aims of our study are:
Aim 1: To assess CAM-specific health care behavior, including bi-national CAM utilization from allied/alternative health personnel (e.g. pharmacists, non-Western medicine healers) among HIV-positive Latinos residing in Tijuana and San Diego.
Hypothesis 1 (H1) Greater use of CAM will be observed among HIV-positive Latinos who report a) crossing the U.S. border more frequently, and b) having migrated to Tijuana or San Diego (e.g. from southern Mexico).
Aim 2: To assess use of CAM in the context of HIV treatment utilization and practices, including factors related to delayed entry into HIV care (e.g. HIV stigma); and access to, utilization of and adherence to ARVs among HIV-positive Latinos residing in Tijuana or San Diego. H2.a) Compared to HIV-positive Latinos who report using herbal CAM, those who do not use herbal CAM are more likely to be using ARVs and report higher levels of adherence to ARVs; H2.b) Compared to HIV-positive Latinos who do not attend religious services regularly, those who attend religious services regularly are more likely to use ARV.
H2.c) Compared to HIV-positive Latinos who report experiencing HIV-related stigma, those who do not report experiencing HIV-related stigma are significantly more likely to use ARVs and report lesser utilization of CAM.
Aim 3: To determine perceived barriers to communicating use of CAM and ARV adherence to clinicians among HIV-positive Latinos residing in Tijuana or San Diego, including satisfaction with clinician communication; concern about physician response to reporting CAM modalities such as herbal therapies, pharmacy practices in Mexico and folk healing perception of ARV efficacy, and perception of ARV efficacy.
H3) Among HIV-positive CAM users, disclosure of CAM use will be higher in Latino patients who report higher satisfaction with communication with clinicians than those who report lower satisfaction with clinicians.
Aim 4: To explore provider and system barriers to culturally-effective communication about CAM and ARV adherence with HIV-positive Latino patients, including clinician knowledge about patient CAM practices.
To address Aims 1-3 we will conduct a quantitative study using interviewer-administered surveys with 200 HIV positive Latinos (100 from each side of the border). In Aim 4 we will purposively sample 20 HIV clinicians on both sides of the border and conduct in-depth interviews. Our aims are consistent with the Office of AIDS Research 2008 Plan to assess sociocultural and structural determinants and health systems that enhance, sustain and/or perpetuate health disparities.7 Capitalizing on our HIV research expertise with Latino communities, this study will lead to development of culturally-effective interventions to improve timeliness and adherence to HIV care in populations with documented health disparities and will reduce gaps in care.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-Positive Latinos living in San Diego or Tijuana | – | –This is an exploratory study of Latinos living with HIV in the San Diego-Tijuana US-Mexico border region. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be selected from 2 locations: 1. San Diego: San Ysidro Health Center(SYHC) will serve as the recruitment site on the US side of the border. Latinos comprise >90% of SYHC's patient population. SYHC provides HIV primary medical care to over 400 HIV-positive individuals. SYHC's HIV-positive Latino patient population includes persons who may or may not be on ARVs and who participate in clinic services to varying degrees. Previous studies with HIV-positive patients at SYHC indicate cross-border mobility and bi-national care seeking behavior in this clinic population. 2.Tijuana: The Agencia Familiar Binacional (AFABI;Binational Health Agency) opened the first HIV medical and social services agency clinic in Tijuana. This clinic is in close proximity to the municipal health clinic, where a large number of HIV-positive cases are diagnosed, and is linked with other non-profit social services agencies for HIV-positive persons, many of whom face barriers to ARVs.
Key inclusion criteria (5 listed)
- Latino
- Speak English or Spanish or both
- Lived in San Diego or Tijuana for at least 1 month in the last year
- 18 years or older
- HIV-positive or living with AIDS
Key exclusion criteria (5 listed)
- Non-Latino
- Speak neither English nor Spanish
- Have not lived in San Diego or Tijuana for at least 1 month in the last year
- Under 18 years of age
- Not HIV-positive or living with AIDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 7 Feb 2020.
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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.
Maria L Zúñiga, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Positive, run by University of California, San Diego at 1 site in United States.
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 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 7 Feb 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 United States. 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.
Where can I read the original study information?
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 7 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.