Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01152684
Other study ID # R21AT004676-01A1
Secondary ID R21AT004676-01A1
Status Completed
Phase
First received
Last updated
Start date September 2009
Est. completion date January 2013

Study information

Verified date February 2020
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 541
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States San Ysidro Health Center San Ysidro California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Diego National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT00639145 - Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol
Completed NCT01957748 - CCTG 594: Engagement and Retention in Care for HIV+ N/A
Completed NCT01818258 - IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children Phase 4
Withdrawn NCT03660722 - Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects N/A
Completed NCT01793467 - Transplantation and the Use of Raltegravir in HIV-Infected Patients N/A
Completed NCT02938377 - Alcohol Research Consortium in HIV-Intervention Research Arm Phase 4
Completed NCT01898754 - Oligonucleotide Ligation Assay (OLA) Resistance Study N/A
Active, not recruiting NCT01365065 - Safety and Effect on HIV Transcription of Vorinostat in Patients Receiving Suppressive Combination Anti-retroviral Therapy Phase 2
Completed NCT00106795 - Relationship Between Fatigue and Mitochondrial Damage in Patients With HIV/AIDS N/A
Not yet recruiting NCT02404233 - Open Label, Pilot Study of Darunavir Boosted by Cobicistat in Combination With Rilpivirine to Treat HIV+ Naïve Subjects Phase 4
Completed NCT01154543 - Safety and Efficacy of Famciclovir in HIV1 Positive Adults With Recurrent Genital Herpes N/A
Completed NCT01154556 - RETRIeVE: ReversE TranscRiptase Inhibitor hiV Practice N/A
Completed NCT00857350 - The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment N/A
Recruiting NCT01875588 - Thinking and Memory Problems in People With HIV
Completed NCT01941121 - CCTG 593: Testing and Linkage to Care N/A
Terminated NCT01904201 - Evaluation of a Blood Test to Measure Immune Function in HIV Positive People Compared With HIV Negative People N/A
Enrolling by invitation NCT00941889 - The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata N/A
Completed NCT03531749 - Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate N/A
Completed NCT02935296 - Integrated Treatment and Prevention for People Who Inject Drugs Phase 3
Completed NCT01536899 - Medical Marijuana Use in HIV+ Patients Prospective Cohort Study