Infections

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Communicable Diseases

Sexually Transmitted Diseases

Urogenital Diseases

Genital Diseases

Disease Attributes

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan (according to a randomization scheme provided by the study team) to be invited to contact and work with a Community health worker. Those not invited will constitute the usual care control group.

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan (according to a randomization scheme provided by the study team) to be invited to contact and work with a Community health worker in the intervention group.

The intervention group will be made up of two sub groups. The group of individuals who accept the invitation to participate (IG1) in the intervention and receive it, and those randomized to the intervention group but who reject the opportunity to participate (IG2).

Community health workers (CHWs) in Hispanic communities, often referred to as "promotoras," are members of the community who use "resource sharing, partnership development, education, outreach, health promotion, and disease prevention strategies to improve the health" of their communities.

IG1: The intervention itself consists of a 45-minute one-on-one presentation and tailored planning session delivered by a CHW in a community setting of the new member's choosing. Presentations (in English or Spanish) will be delivered using a tablet computer or a hand held flipchart. Two booster telephone interactions will be performed at 2 and 4 months. At month 6, the participant will receive a call from the telephone interviewer to administer the informed patient choice survey.

Community health worker

Franciso AR Garcia, MD, MPH

The investigators propose to test a community-developed and targeted intervention that employs community health workers (CHWs) as aides to newly Medicaid-insured women. These women face the challenges of engaging with their healthcare and health and of making highly personal and socioculturally embedded decisions about reproductive health-related preventive services (e.g., contraception, STI and cancer screening).

All newly enrolled women in one of Arizona's state-wide Medicaid health plans (University Family Care) who are ambulatory and community-dwelling, and between the ages of 18-39, will be identified by the health plan on a monthly basis as eligible for this study. For at least the first month, these new health plan members will be randomized 2 to 1 (intervention to usual care control). Each month the health plan will provide the study team with the number of new members. A study team member will then provide the health plan with a list of numbers (1's and 0's) generated using the biased coin design to apply to those new members. To avoid bias, health plan staff will not be aware of members study arm.

All new health plan enrollees (as per current standard health plan practice) receive a series of welcome communications (by mail and electronically) from the health plan shortly after enrollment. These are designed to apprise new members of health plan policies and procedures related to covered benefits, facilitate the selection of a primary care provider, and provide general preventive health resources and information. This is followed by a second mailing at 3-months post enrollment, as well as a nurse follow-up call. The latter is designed to answer questions about covered services, finding a primary care provider, and/or otherwise provide support. Both intervention and control group member will receive identical communications from the health plan up to this point. Potential participants will be contacted by the health plan's call center. A brief verbal overview of the intervention including time requirement and content to be covered will be provided. The potential participants who have been randomly assigned to the intervention group will then be offered the opportunity to set up an individual confidential appointment with a community health worker (CHW) at her earliest convenience.

The call center will provide the research office a list of interested participants and their contact information. Once that list is received by the research office, a CHW will be assigned to each potential participant. The assigned CHW will call to introduce herself, to answer lingering questions about the intervention and proposed encounter and to confirm the participant's acceptance into the intervention. At that time, the CHW will confirm language and location preference, date/ time of proposed meeting, and the contact information for the research office for any questions. The CHW will meet with the subject and complete the informed consent process. Also, the baseline informed patient choice survey will be performed using a touch tablet device (to ascertain baseline knowledge, patient preferences, informed decision making, and health literacy). The CHW will tailor the individual education session to meet the unique needs of the participant (e.g., an individual who discloses a history of surgical sterilization will not receive information about contraception). The 45-minute intervention will be delivered as described above. The patient will be asked to personally assess her needs with regard to reproductive health-related issues. The CHW will work with the participant to develop a personalized plan to access the relevant targeted preventive services. This may involve assistance with contacting the Health Plan and assistance with identifying or making an appointment with a primary care provider. At the conclusion of the intervention, the patient will be encouraged to reach out to the CHW by telephone or electronically if she has any subsequent questions or concerns, and appointments for the two booster telephone calls will be scheduled. Finally, in consideration for her time and participation, the participant will be provided with a $40 gift card.

Booster telephone support calls will occur at 2 and 4 months post intervention. A telephone call guide will be used to reinforce and clarify key concepts from the initial intervention encounter as well as to help clients formulate relevant questions related to specific women's preventive services and other health concerns in anticipation of their next primary care provider (PCP) visit. Participants will also be queried specifically about any issues related to interactions with the health plan and/or contacting her primary care provider. The patient will be assisted with connecting to the health plan or her PCP's office for those issues that cannot be easily addressed by the CHW. Whenever possible, every effort will be made by the CHW to connect the patient to the appropriate outreach staff at that PCP's office (if such staff is available). Again the availability of the CHW by telephone or electronically for interval questions will be emphasized. At month 6, the participant will receive a call from the telephone interviewer to administer the 6-month informed patient choice survey identical to the survey that was completed at baseline. A $40 gift card incentive will be offered to complete this survey.

The call center will administer a similar 6-month survey by phone to a sample of the group randomized to invitation, but who did not accept the invitation (IG2) and the group not invited (CG). A $30 gift card incentive will be offered to complete this survey.

Connecting Healthy Women: Examining the Effect of an Intervention From the Effect of Being Reachable

The short form of the Patient Activation Measure (PAM), a measure of patient engagement in their healthcare. PAM levels of engagement with Level 4 being the highest level.

The number and percentage of new members who had at least one visit with a primary care provider during their first 6 months of enrollment.

The number and percentage of new members who had at least one preventive visit (i.e., well woman visit, cervical cancer screening, sexually transmitted infection (STI) screening, STI counseling, contraception counseling or immunizations) during their first 6 months of enrollment.

The number and percentage of new members who had avoidable emergency department (ED) visits during their first 6 months of enrollment.

The number and percentage of new members who had avoidable hospitalizations during their first 6 months of enrollment.

Patient-Centered Outcomes Research Institute

RAND

University of Arizona

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited will constitute the usual care control group.

Control Group (CG)

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

The intervention group will be made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.

Intervention Group (IG1)

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

The intervention group will be made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.

Intervention Group (IG2)

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group..

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The health plan was unable to contact the majority of the population to make the offer of CHW services, and the young, generally healthy population made impacts on avoidable ED visits and hospitalizations difficult to detect within a 6 month period.

Dr. Ada Wilkinson-Lee, Co-Investigator

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group.

Identify and Utilization of Primary Care Provider (PCP)

The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services

Members who had an ED visit during the first 6 months of their enrollment.

The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits

Members who had a hospital visit during the first 6 months of enrollment.

The Impact of the Intervention on Preventable Hospital Stays

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

IG1 at Baseline: The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.

Baseline: Intervention Group (IG1)

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group.

IG1 at 6-Month Follow-up: The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.

6-Month Follow-up: Intervention Group (IG1)

Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker.

CG and IG2 at 6-Month Follow-up: Those not invited constituted the usual care control group (CG). The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.

6-Month Follow-up: Control Group (CG)&Intervention Group (IG2)

IG1 group members that completed the baseline and 6-month survey and CG and IG2 group members that complete the 6-month survey.

Informed Decision Making Regarding the Healthcare System and Their Health

Overall Study

Skin and Connective Tissue Diseases

Immune System Diseases

Rare Diseases

Syphilis

Herpes Simplex

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Chlamydia Infections

Gonorrhea

Virus Diseases

Vaginosis, Bacterial

Vaginal Diseases

Trichomonas Infections

Cervical Intraepithelial Neoplasia

Leandro A Mena, MD, MPH

The purpose of this study is to determine the rates of sexually transmitted infections (STI) among a group of African American women who have sex with women (AA WSW). The first study hypothesis is that AA WSW are at risk for acquiring and transmitting STI, including the human immunodeficiency virus (HIV). The second study hypothesis is that AA WSW participate in multiple high-risk sexual activities that may facilitate transmission of STIs, including HIV.

Historically, women who have sex with women (WSW) have been thought to be at low risk for acquiring sexually transmitted infections (STI), presumably due to the absence of genital mucosal contact present during vaginal-penile sex or due to the assumption that the vaginal mucosa experiences a lesser degree of trauma during female sex than during heterosexual sex. This assumption has been challenged and debated over the past two decades. In addition, the sexual health risks of WSW are only beginning to be understood.

To date the majority of research regarding STI in women has occurred in heterosexuals. National and local surveillance data that estimate the risk for STI transmission between WSW are limited, especially among African Americans. This is a group of women that may exhibit distinctive behavioral characteristics that may put them at higher risk for sexually transmitted infections STI and HIV than their Caucasian counterparts. This group of women has traditionally been reluctant to discuss their sexual orientation with physicians for fear of being stigmatized. The burden of STIs, including HIV, experienced by this group of women is largely unknown.

Endocervical and vaginal secretion specimens are being retained for future research studies in this field of sexually transmitted diseases.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Connecting Healthy Women: Examining the Effect of an Intervention From the Effect of Being Reachable	NCT02157168	Contraception Sexually Transm... Cervical Cancer	Community healt...	18 Years - 39 Years	University of Arizona
Sexually Transmitted Infections Among African American Women Who Have Sex With Women	NCT01043081	Sexually Transm... HIV Infections		18 Years -	University of Mississippi Medical Center
Sexually Transmitted Infections Among African American Women Who Have Sex With Women	NCT01043081	Sexually Transm... HIV Infections		18 Years -	University of Mississippi Medical Center
Sexually Transmitted Infections Among African American Women Who Have Sex With Women	NCT01043081	Sexually Transm... HIV Infections		18 Years -	University of Mississippi Medical Center
Sexually Transmitted Infections Among African American Women Who Have Sex With Women	NCT01043081	Sexually Transm... HIV Infections		18 Years -	University of Mississippi Medical Center

Spots Global Cancer Trial Database for sexually transmitted infections