PARTNER NOTIFICATION TO HIV-INFECTED DRUG USERS

NIH GUIDE, Volume 22, Number 33, September 17, 1993



PA NUMBER:  PA-93-111



P.T. 34



Keywords:

  AIDS 

  Drugs/Drug Abuse 

  Sexually Transmitted Diseases 



National Institute on Drug Abuse



PURPOSE



The purpose of this program announcement is to encourage research on

comprehensive partner notification programs targeted to HIV-positive

drug users and their sexual and/or needle-sharing partners.  Support

will be provided for the development of new community-based

methodologies/strategies for client and third-party notification, the

selection/adaption of existing notification models, and the

subsequent implementation, testing, and evaluation of effectiveness

of the methodologies in terms of identification of partners,

reduction in risk behavior, and prevention of spread of HIV.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This program

announcement, Partner Notification to HIV-Infected Individuals, is

related to the priority area of alcohol and other drugs.  Potential

applicants may obtain a copy of "Healthy People 2000" (Full Report:

Stock No. 017-001-00474-0 of Summary Report:  Stock No.

017-001-00473-1) through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by foreign and domestic, for-profit and

non-profit, public and private organizations such as universities,

colleges, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal government.  Women

and minority investigators are encouraged to apply.  Applicants are

especially encouraged from State and municipal governments with

outreach units and/or State and municipal governments collaborating

with university-based research units.



MECHANISM OF SUPPORT



This program announcement will use the National Institutes of Health

(NIH) individual research grant (R01).  Responsibility for the

planning, direction, and execution of the proposed project will be

solely that of the applicant.  Support will be provided for a period

of up to five years (renewable for subsequent periods) subject to

continued availability of funds and progress achieved.  Because the

nature and scope of the research proposed in response to this program

announcement may vary, it is anticipated that the size of an award

will vary also.



RESEARCH OBJECTIVES



Summary



Following initial exploratory investigations on issues related to the

process of HIV-seropositivity disclosure and its consequences,

carefully controlled studies are sought to implement and determine:

(1) which strategies are most effective in reaching seropositive drug

users and motivating them to disclose their serostatus to their

sexual/needle-sharing partners; (2) the effects of combining partner

notification with current HIV outreach/prevention activities; and (3)

evaluation of new and existing methodologies for patient and

third-party partner notification models for drug users.



Sub-objectives include:  (a) evaluation of different notification

strategies on voluntary HIV testing for at-risk needle-sharing

injection drug users and/or sexual partners; (b) identifying subgroup

characteristics as a function of which partner notification model is

selected; (c) assessing the degree to which index individuals are

compliant with the selected model; (d) analyzing the changes in

behavioral risk reported among individuals with different risk

behaviors (e.g., type of partner--needle-sharing versus high-risk

sexual contacts) as a function of selected model and subsequent

compliance; (e) extent to which identified sexual/needle-sharing

partners seek HIV counseling and testing; (f) analyzing the changes

in behavioral risk reported by informed partners with different risk

behaviors (needle-sharing versus high-risk sexual contacts); (g)

evaluating the extent and duration of psychological and social impact

of HIV seropositive partner notification on both index and partners'

drug-using, needle-sharing and sexual relationships; and (h)

determining risk factors and rates of HIV transmission in

serologically discordant injection partners receiving risk reduction.



Applicants may focus on and recruit drug users from a variety of

settings including individuals who are currently involved in

traditional drug treatment programs or drug users who cannot or do

not wish to currently access drug treatment and are identified

through community-based outreach efforts.  There exists a paucity of

data regarding issues related to disclosure and its consequences.  As

a result, it may be necessary to obtain data from exploratory studies

to address issues surrounding the process of HIV-seropositivity

disclosure using qualitative strategies and methodological approaches

to better understand this process prior to program development,

implementation, and evaluation.  It is also important to explore and

understand the consequences of disclosure and determine the

differential impact on risk behaviors for men and women and across

various racial/ethnic groups.



Background



The National Institute on Drug Abuse (NIDA) recognizes the importance

of understanding the extent to which HIV prevention efforts exist or

can exist for drug users at risk for HIV infection.  It is

particularly important to demonstrate the extent to which drug users

will voluntarily obtain HIV testing and counseling, as well as to

ascertain their willingness and ability to inform drug users with

whom they have shared needles or sexual partners of their HIV

antibody seropositivity.  It is also important to:  (1) understand

the barriers, processes, and consequences of such disclosure; (2)

determine the differential impact of disclosure for men and women and

across various racial/ethnic groups; and (3) ultimately, to determine

the impact of disclosure on the spread of HIV infection to others.



Between June 1981 and June 30, 1993, more than 300,000 AIDS cases in

the U.S. were reported to the Centers for Disease Control and

Prevention (CDC).  Approximately 30 percent of the AIDS cases are

among injecting drug users.  Heterosexual IDUs account for 23 percent

of AIDS cases, whereas homosexual and bisexual IDUs account for an

additional six percent.  Nineteen percent of all male cases were

heterosexuals who reported using needles for self-injecting of drugs

not prescribed by a physician at least once prior to developing AIDS.

Half of all females with AIDS also reported a self-injection drug-use

history.  Although AIDS diagnoses among homosexual and bisexual men

and among injecting drug users are projected to reach a plateau

during this decade, the number of AIDS diagnoses among persons whose

HIV infection is attributed to heterosexual transmission of HIV is

likely to continue to increase through 1994.



Outcome data from studies investigating seroprevalence among persons

identified as sex or needle-sharing partners of HIV-infected

individuals show HIV positive rates ranging from 11 percent to 39

percent (Vernon et al., 1988).  In analyzing data from the first

cohort of study sites involved in NIDA's Cooperative Agreement for

AIDS Community-Based Outreach/Intervention Research Program, almost

29 percent of HIV positive drug users reported giving their used

needles (works) to other IVDUs while 46 percent of HIV-negative IVDUs

are injecting with used needles.  It is unknown whether or not any

disclosure of HIV seropositivity is occurring among the

needle-sharing individuals.  Since it is apparent that these

individuals are engaging in high-risk behavior, it is important to

study barriers to disclosure.  It is estimated that there are a

significant number of drug users who have not been reached through

standard AIDS education program efforts or the drug treatment system

to receive risk-reduction counseling and education, particularly

those who are the male or female sexual partners of drug users, who

may have been exposed to HIV infection, but who may be unaware of

their risk.  Additionally, partner notification activities directed

toward women may help in preventing the perinatal transmission of

HIV.  Out-of-treatment drug users recruited in NIDA's ongoing

community-based efforts often have no previous drug treatment

experience (40 percent) and many report no prior history of having

been tested for HIV (35 percent).  These data emphasize the need to

study diverse populations of individuals, particularly the

hard-to-reach out-of-treatment injection drug-using populations.



Since the implementation of partner notification in 1936 as part of a

national syphilis prevention program in the United States, sexually

transmitted disease (STD) control centers have identified and

informed a number of otherwise unsuspecting individuals of their

potential exposure to an STD, thus, allowing them to receive rapid

and effective intervention.  Traditionally, two complementary

processes have been used to notify the partners:  (1) patient

referral where the infected partner assumes the responsibility to

inform their own sexual partners and refer them for counseling and

testing; (2) contract patient referral which differs from patient

referral in that while index clients are encouraged to inform their

own sex and needle-sharing partners, locator information will be

collected on partners that are voluntarily identified by the index

client and if the index client is unable to notify the partner(s) in

three working days, a disease intervention specialist (DIS) outreach

worker will initiate the provider referral.  Whereas some combination

of these strategies continues to be the mainstay of STD control

programs, there have been no community-based evaluations for

effectiveness in preventing disease transmission or lowering rates of

disease in injection drug users at STD programs.



Most recently, partner notification has been applied for the

prevention of HIV infection.  In the AIDS Surveillance and Prevention

Cooperative Agreements supported by the CDC, States are required to

design and implement procedures for the confidential notification of

sex and needle-sharing partners of AIDS patients and HIV-positive

individuals.  Whereas this is currently being implemented in all

publicly funded clinics, little data exist on the role of partner

notification in preventing HIV transmission.  Wykoff et al. (1988,

1989) documented the outcome of provider referrals in a rural area in

South Carolina with low HIV seroprevalence.  Of 316 sex and

needle-sharing partners of HIV-positive individuals who were named in

a single health district over a two-year period, 66 percent were

contacted and agreed to be tested.  Of these, 18 percent were found

to be infected with HIV.  Subsequent follow-up indicated that risk

behaviors significantly decreased for both infected and uninfected

partners following notification and counseling.  The Centers for

Disease Control and Prevention (Division of STD/HIV Prevention)

conducted an evaluation of partner notification activities based in

STD clinics for HIV and syphilis prevention.  This multi-site

evaluation focused on the randomized assignment of index patients to

existing partner notification strategies to assess the ability of the

strategies to identify individuals at risk for infection by measuring

which methods of partner notification result in the largest number of

partners presenting for testing.  A behavioral follow-up portion of

the evaluation has not been implemented at this time.  In addition, a

limited amount of information was gathered on the needle-sharing

partners of those HIV-positive injecting drug users.  It should,

therefore, be emphasized that significant gaps in research remain.

For example, would the same results be achieved via other contacts?

Is education without notification equally effective?  While there

remains a strong need for disclosure regarding infection status,

there are substantial barriers and problems regarding disclosure,

particularly for individuals with few resources.



Since knowledge of serostatus appears to have a positive moderating

effect on risk behavior, there is a clear and critical need to

identify the presence of HIV at the earliest opportunity through a

confidential HIV testing and counseling program.  In addition to HIV

counseling and testing of a drug user at time of entry into treatment

or at community clinics, one aspect of comprehensive client services

can involve partner notification efforts to provide counseling and

testing services to this otherwise potentially hidden at-risk

population.  If the sex and/or needle-sharing partners are found to

be infected, they, too, can receive early intervention for HIV

disease, and transmission of disease could be interrupted.

Additionally, studying networks of users and following the chain in

the referral process from HIV infected individuals to other

individuals in their drug-using networks can provide critical

information about the future prospects of the epidemic.



As noted in this section, NIDA and CDC have collaborated, and will

continue to collaborate, in the development and implementation of

this program announcement.



Program Description



Applicants are advised to review existing information relevant to

partner notification and to commit to providing additional basic

knowledge to a field that is currently lacking in such.  Following

analysis of information obtained via informal disclosure and/or

observation studies, applicants will develop  methodologies and

design controlled studies to determine the impact of new/existing

methodologies (patient and third-party partner notification) for

HIV-positive partner notification on prevention/treatment efforts and

the degree of effectiveness in altering at-risk behaviors in the

HIV-positive person and those that he or she informs.  Issues of

general concern include understanding who selects which model, the

level of compliance, where applicable, with the model and the

subsequent behavioral and psychological impact as a function of

adoption and compliance for all individuals.  It is also of primary

interest to evaluate how barriers to informal disclosure differ from

those encountered in formal programs as well as to understand whether

or not the barriers are different for men and women and what effects

this may have.  Additionally, this project should document issues and

impediments affecting public health, medical and social support,

community services, and strategies that can be used to overcome these

difficulties.



The importance of a sound research plan and qualified research staff

cannot be over-emphasized.  It is recommended that investigators use

the most rigorous methodology (qualitative and quantitative)

consistent with the purposes of the research.  Where controlled

trials are not feasible, other types of controls may be used,

including case control, equivalent comparison groups, or other

designs.  While many treatment and/or community agencies do not have

a research department, applicants may wish to enter into

collaboration with well-qualified researchers.  Applicants are

strongly urged to address issues of project feasibility and

collaborative arrangements, study design, sampling procedures,

implementation of client assignment to the interventions,

instrumentation and measurement, data collection, quality control,

tracking of clients, follow-up, and data analyses, as appropriate.

It is essential that the applicant discuss the potential barriers to

implementing this type of study and discuss strategies to deal with

these issues.  Particularly critical to discuss are issues related to

collaboration, confidentiality, number of subjects, anticipated staff

and further types of substudies.  It is critical that power analyses

to support cell size and overall number of study participants be

included to insure adequate numbers to test different hypotheses.  It

is also expected that applicants will demonstrate a clear

understanding of the social, legal, political, and ethical arguments

and ramifications involved with research related to partner

notification and strategies to effectively increase disclosure of HIV

status.



Investigators are required to offer HIV testing and counseling in

accordance with current guidelines to subjects identified as being at

risk for HIV acquisition or transmission.  In high-risk populations,

investigators are encouraged to assess the effects of new

interventions on the acquisition and transmission of infectious

diseases, including HIV.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements will be required to include minorities and

women in study populations so that research findings can be of

benefit to all persons at risk of the disease, disorder or condition

under study; special emphasis should be placed on the need for

inclusion of minorities and women in studies of diseases, disorders

and conditions which disproportionately affect them.  This policy is

intended to apply to males and females of all ages.  If women or

minorities are excluded or inadequately represented in clinical

research, particularly in proposed population-based studies, a clear

compelling rationale should be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study.  This information should be included in the form PHS 398

in Sections 1-4 of the Research Plan AND summarized in Section 5,

Human Subjects.



Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However,

NIH recognizes that it may not be feasible or appropriate in all

research projects to include representation of the full array of

United States racial/ethnic minority populations (i.e., Native

Americans (including American Indians or Alaskan Natives),

Asian/Pacific Islanders, Blacks, Hispanics).



The rationale for studies on single minority population groups should

be provided.



For the purpose of this policy, clinical research includes human

biomedical and behavioral studies of etiology, epidemiology,

prevention (and preventive strategies), diagnosis, or treatment of

diseases, disorders or conditions, including but not limited to

clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



If the required information is not contained within the application,

the application will be returned.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and will be

reflected in assigning the priority score to the application.



All applications for clinical research submitted to NIH are required

to address these policies.  NIH funding components will not award

grants or cooperative agreements that do not comply with these

policies.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application PHS 398

form (rev. 9/91) and will be accepted at the standard AIDS-related

application deadlines as indicated in the application kit.



Application kits are available at most institutional offices of

sponsored research and may be obtained from the Office of Grant

Information, Division of Research Grants, National Institutes of

Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone

301-710-0267.  The title and number of the announcement must be typed

in Item 2a on the face page of the application.



The completed original and five permanent, legible copies of the PHS

398 form must be submitted to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



The Division of Research Grants, NIH, serves as a central point for

receipt of applications for most discretionary DHHS grant programs.

Applications received under this announcement will be assigned to an

initial review group (IRG) in accordance with established PHS

referral guidelines.  The IRGs, consisting primarily of non-Federal

scientific and technical experts, will review the applications for

scientific and technical merit in accordance with the standard NIH

peer review procedures.  Notification of the review recommendations

will be sent to the applicant after the initial review.  Applications

will receive a second-level review by an appropriate Advisory

Council, whose review may be based on policy considerations as well

as scientific merit.  Only applications recommended for further

consideration by the Council may be considered for funding.



AWARD CRITERIA



Applications recommended for further consideration by an appropriate

Advisory Council will be considered for funding on the basis of

overall scientific, clinical and technical merit of the application

as determined by peer review, appropriateness of budget estimates,

program needs and balance, policy considerations, adequacy of

provisions for the protection of human subjects, and availability of

funds.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Richard Needle, Ph.D., M.P.H.

National Institute on Drug Abuse

5600 Fishers Lane, Room 9-A-30

Rockville, MD  20857

Telephone:  (301) 443-6720



Direct inquiries regarding fiscal matters to:



Chief, Grants  Management Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 8-A-54

Rockville, MD  20857

Telephone:  (301) 443-6710



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.279.  Awards are made under authorization of the

Public Health Service Act, Section 301 and administered under PHS

policies and Federal Regulations of Title 42 CFR 52 "Grants for

Research Projects", Title 45 CFR Part 74 and 92, "Administration of

Grants" and 45 CFR Part 46, "Protection of Human Subjects".  Title 42

CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient

Records" may be applicable to these awards.  Title 42 Part 241(d)

"Certificates of Confidentiality and Communicable Disease Reporting"

will also apply.  This program is not subject to the

intergovernmental review requirements of Executive Order 12372.BREAST

CANCER:  ETIOLOGY AND PREVENTION



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