Implementation Research for Vulnerable Women in South Africa

This five-year implementation science study is using cluster-randomized stepped-wedge design
to evaluate the implementation, service, and patient outcomes associated with the WHC for
alcohol and other drug (AOD)-using HIV positive women in usual care settings.

A list of four substance use treatment clinics and four HTC/healthcare clinics, which have
been identified and approved by the City of Cape Town, South Africa will be randomized to
begin the intervention during one of the four cycles. Each HTC/healthcare clinic will be
paired with a substance rehab center based on geographic proximity, and each pair was
randomized by computer into four succeeding 6-month implementation cycles where
implementation of the WHC is taking place simultaneously at the paired sites. Up to 120 HIV
positive participants will be recruited in each cycle (60 from each clinic) for the patient
level outcomes.

Both qualitative and quantitative data will be collected to assess the appropriateness of
marketing plans developed through formative methods, as well as the acceptability, adoption,
feasibility, fidelity, and sustainability of the WHC intervention implementation as well as
service outcomes (comprehensive services and timely service linkages) during each
implementation cycle.

Each implementation cycle will last 6 months, with a "1-month formative lesson learned"
evaluation. Subsequently, we will collect post-intervention data from each cycle. The process
repeats itself over each cycle and these formative periods between cycles will be used to
inform backward- and forward- implementation strategies, make modifications to the WHC, and
leave time for site-specific training for the next cycle. Consequently, the sites randomized
to the first cycle will have the longest post-intervention observation period whose
implementation sustainability will be checked through fidelity forms and sustainability
questionnaires, and sites in fourth cycle will benefit the most from the pre-intervention
data because of lessons learned and information shared in pre-focus groups.

The intervention will be implemented in a group, however there may be instances when only one
participant is available and therefore the intervention will be implemented one-on-one. The
WHC has previously been tested in group and one-on-one formats and both have demonstrated
consistent significant intervention effects. Research staff will train clinic staff members
to deliver the intervention. The intervention will be delivered by clinic staff and will not
be part of the research. The research questions are related to the feasibility of
implementing the intervention in clinics and its acceptability to clinic staff and patients.
We will collect information on patient-level outcomes to determine if the intervention is
effective when it is delivered by clinic staff to patients in the clinic. Also, to assess
acceptability of the intervention sessions among patients, we will conduct
post-implementation focus groups with a randomly selected sub-sample of participants who
participated in the intervention and completed their final 6-month appointment in each
implementation cycle.

Implementation of the WHC in usual care settings has the potential to reach more vulnerable
women and could have a high public health impact if implementation is shown to be effective
and sustainable in these real-world settings.

Clinic Inclusion Criteria:

- HIV/antenatal clinic or substance abuse treatment clinic

- Located in townships surrounding Cape Town

- Willing to take part in study

Patient Inclusion Criteria:

- Female;

- 18 to 45 years of age;

- Reports use of at least one drug, including alcohol, at least weekly during the
previous 3 months;

- Reports unprotected sex with a male partner in the past 6 months;

- Has a positive HIV test result from either the participating health clinic or rehab
clinic, or a clinic issued ARV card or ARV medication as proof of positive status;

- Reports the intention to remain in the area for the at least the next 6 months;

- Provides informed consent to participate.

Patient Exclusion Criteria:

- Not HIV Positive

- Not willing to do alcohol and drug screening