[Site Name]

Study-Specific Standard Operating Procedure

SOP Number: [NNN]

SOP Title: HIV-Related Counseling for IMPAACT P1115
Original Effective Date: [insert date]
Revision Effective Date: Not Applicable

Purpose
To define requirements and procedures for providing HIV-related counseling in IMPAACT
P1115.

Scope
This standard operating procedure (SOP) applies to all study staff involved in providing HIV-
related counseling in P1115.

Responsibilities

 [SPECIFY WHO] are responsible for providing HIV-related counseling in P1115 in

accordance with this SOP.

 [SPECIFY WHO] is responsible for training counseling staff (as listed above) to provide
HIV-related counseling in accordance with this SOP and for providing day-to-day
oversight and support to counseling staff to ensure that this SOP is followed.

 P1115 Investigator of Record (IoR) is ultimately responsible for ensuring that all
applicable study staff follow this SOP.

Procedures
1. Overview of Counseling Procedures

Procedures are described below for HIV-related counseling provided in P1115 in the
following contexts:

 Counseling provided in relation to maternal HIV testing

 Counseling provided in relation to infant HIV testing
 Counseling provided in relation to reduction of secondary transmission risk

All counseling will be provided in a client-centered manner and in accordance with the
following applicable policies and guidelines [LIST ALL RELEVANT POLICIES AND
GUIDELINES IN THE BULLETS BELOW:

 [Counseling Policy/Guideline/Reference A]
 [Counseling Policy/Guideline/Reference B]
 [Counseling Policy/Guideline/Reference C]

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Copies of the above-listed policies and guidelines are attached to this SOP.

2. Counseling in Relation to Maternal HIV Testing

P1115 will enroll HIV-infected women and their infants. Women are generally expected to be
referred to the study after having undergone HIV counseling and testing outside of the study.
However, it may be necessary for study staff to perform HIV testing confirm infection (see
protocol Section 4.111). When study staff are required to perform maternal HIV testing, all
such testing will be performed in the context of pre-test and post-test counseling. All
counseling will be provided in accordance with the policies and guidelines listed in Item 1.

3. Counseling in Relation to Infant HIV Testing

Infants enrolled in P1115 will be tested for HIV infection per the relevant protocol Schedules
of Evaluations. At designated testing time points, pre-test and post-test counseling will be
provided to the infant’s mother. This counseling may also be provided to the infant’s father
or legal guardian. All counseling will be provided in accordance with the policies and
guidelines listed in Item 1.

When infants test positive for HIV infection, mothers (and/or fathers and legal guardians)
may require additional post-test counseling in order to support proper understanding and
coping with the test result. Additional counseling sessions will be scheduled as required
based on participant needs. Infants with confirmed infection will be retained in P1115 long
term. For infants found to be uninfected, post-test counseling will include active referrals to
non-study sources of infant care and prophylaxis, consistent with local standards of care. All
referrals will be documented and followed up as described in Item 5.

4. Risk Reduction Counseling

For this study, the term “risk reduction counseling” refers to counseling provided to study
mothers to reduce their risk of re-infection and their risk of transmitting HIV to others. For
mothers of infected infants, counseling should also address potential risks of transmission
from the infant. The P1115 protocol does not specify requirements for providing risk
reduction counseling; however, risk reduction counseling will be provided as part of the pre-
and post-testing counseling described above, and will additionally be provided to any mother
upon her request. All counseling will be provided in accordance with the policies and
guidelines listed in Item 1.

Condoms will be provided to all mothers free of charge throughout their participation in the
study, and risk reduction counseling will include information/education as well as skills
building on condom use and condom negotiation strategies as needed for each mother.

Counseling will also include HIV/AIDS education, discussion of disclosure issues and
emotional support, discussion of healthy living strategies, discussion of stressors and
potential strategies to address these, and provision of referrals, as applicable to each mother.
When applicable, counseling will also address the benefits of HIV counseling and testing for
couples.

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5. Referrals

Counseling provided in P1115 may identify needs that are beyond the scope of the study to
address. When such needs are identified, participants will be referred to non-study service
providers and other organizations that may be able to assist them. [SPECIFY WHO] will
maintain a list of referral providers and make this list available to all study staff for use
during all counseling sessions.

At each counseling session after a referral is made, the counselor will actively follow up on
the referral to determine whether the participant sought the services to which she was
referred, determine the outcome of the referral, and determine whether additional referrals are
needed. Additional counseling may also be needed to help ensure the participant received
services that may be beneficial to her or her infant. All follow-up actions, outcomes,
counseling, and plans for next steps will be documented in chart notes.

6. Documentation

All counseling will be documented in participant study records, specifically in chart notes
[OR, IF CHECKLISTS OR OTHER WORKSHEETS ARE PLANNED TO BE USED,
SPECIFY THAT HERE INSTEAD OF CHART NOTES]. Documentation will include the
content of each counseling session, participant responses to the counseling provided, any
concerns raised by the participant, action planned to be taken by the participant prior to the
next counseling session, action to be taken by the counselor (or other study staff members)
prior to the next session, and issues to be reviewed or addressed at the next session. Referrals
will also be documented as described in Item 5 above.

Definitions
[Add as needed after SOP content is finalized]

List of Abbreviations and Acronyms

[Add as needed after SOP content is finalized]

Attachments
 [Counseling Policy/Reference A]
 [Counseling Policy/Reference B]
 [Counseling Policy/Reference C]
 [Any other relevant documents]

References
 IMPAACT P1115 Protocol
 [Counseling Policy/Reference A]
 [Counseling Policy/Reference B]
 [Counseling Policy/Reference C]
 [Any other relevant references]

History

Version Effective
Number Date Supersedes Review Date Change

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 [insert] [insert] NA NA NA (initial release)

Approvals

[INSERT NAME], SOP Author Date

[INSERT NAME], SOP Reviewer Date

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