Partners-based HIV Treatment for Sero-concordant Couples Attending Antenatal Care
Phase: NA
Conditions: Human Immunodeficiency Virus
Sponsor: Vanderbilt University Medical Center

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Partners-based HIV Treatment for Sero-concordant Couples attending Antenatal Care 
 
NCT: NCT03149237 
 
Document date: Jun 17, 2022 
 
 
 
 
 

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STUDY PROTOCOL 
 
PROJECT TITLE: Partners-based HIV Treatment for Sero-concordant Couples attending 
Antenatal Care 
 
 
Date 
17 February 2017 
Principal Investigators 
Dr. Carolyn M. Audet, PhD, Institute for Global Health 
Vanderbilt University, USA 
Funding Agency 
National Institute of Mental Health (NIMH) 
(Dr. Carolyn M. Audet, PI) 
Location 
Zambézia Province - Mozambique 
Expected Start Date 
1 July 2017 
Expected End Date 
30 June 2022 
Type of Study 
Cluster Randomized Controlled Trial  
Main objective 
The overall goal of this project is to develop and assess 
the impact of a partner-based ART delivery intervention 
among HIV-positive expectant couples. 
Key words 
Elimination of Mother to Child Transmission  
Male-engagement 
HIV care 
Antenatal care 
Community Health Worker 
 

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 Table of Contents 
Table of Contents 
Acronyms ...................................................................................................................................................... 4 
1. Principal Investigator ................................................................................................................................ 5 
2. Funding...................................................................................................................................................... 5 
3. Collaborators ............................................................................................................................................. 5 
4. Introduction and Justification ................................................................................................................... 6 
5. Objectives .................................................................................................................................................. 7 
6. Design and Study Questions ..................................................................................................................... 8 
7. Study Population ....................................................................................................................................... 9 
8. Methods .................................................................................................................................................. 10 
9. Locations of Study ................................................................................................................................... 14 
10. Data Management and Analysis ........................................................................................................... 14 
11. Ethical Considerations ........................................................................................................................... 18 
12. Limitations ............................................................................................................................................. 19 
13. Dissemination Plan ................................................................................................................................ 19 
14. Budget ................................................................................................................................................... 19 
15. Timeline ................................................................................................................................................. 20 
16. Bibliography .......................................................................................................................................... 22 
Appendix 1: Couples Education and Training Sessions ............................................................................... 29 
Appendix 2: Measures used in study .......................................................................................................... 32 
Appendix 3: Patient Health Questionnaire – 9 (PHQ-9) ............................................................................. 37 
Appendix 4: Informed Consent (intervention arm) .................................................................................... 39 
Appendix 5: Informed Consent (control arm) ............................................................................................. 42 
 
 
 
 
 

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Acronyms  
 
AIDS 
Acquired Immune Deficiency Syndrome 
ART 
Antiretroviral Therapy 
APSS 
HoPS 
RCT 
Psychosocial Support (Apoio Psicossocial para a Saúde) 
Homens para Saúde “Men for Health” 
Randomized controlled trial 
DPS 
Provincial Directorate of Health 
EPTS 
Electronic patient tracking system 
FGH 
Friends in Global Health 
GoM 
Government of Mozambique 
HCW 
Health care worker 
HIV 
Human Immuno-deficiency Virus 
MOH 
Ministry of Health 
PLHIV 
People Living with HIV 
PMTCT 
EMTCT 
ANC 
EID 
SOC 
Prevention of Mother to Child Transmission 
Elimination of Mother to Child Transmission 
Antenatal Clinic 
Early infant diagnosis 
Standard of care 
VUMC 
Vanderbilt University Medical Center 
WHO 
World Health Organization 
 
 
 
 
 
 

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1. Principal Investigator 
 
The principal investigator (PI) for this evaluation will be Carolyn Marie Audet at Vanderbilt 
University Medical Center. The PI will be responsible for all aspects of evaluation coordination, 
including design, implementation, and analysis.  
 
Contact information for PI:  
 
Carolyn Audet, PhD.    
Vanderbilt University Medical Center 
Department of Health Policy  
2525 West End Ave 
Suite 750 
Nashville, TN 37203 
carolyn.m.audet@vanderbilt.edu 
Phone: 1-615-343-2418 
 
2. Funding 
 
This project will be funded by a National Institute for Mental Health R01 award (PI. Audet). 
 
3. Collaborators 
 
Various project staff from the Ministry of Health (MOH) and FGH/Vanderbilt University Medical 
Center (VUMC) will be involved in this activity. From the MOH, this includes an assigned 
member of the Operational Investigation Committee of Zambézia (NIOZ). From FGH, this 
includes Sara van Rompaey, M.D., M.P.H.; Lazaro Calvo, Ph.D; and Fernanda Alvim, M.P.H. 
From VUMC this includes Carolyn Audet, Ph.D, Erin Graves, N.P., MPH; and Heather Jordan, 
M.P.H. 
 
Table 1. Other participants in the study. 
 
Name  
Organization 
Role 
Role in the Evaluation 
Focal person TBD 
MOH 
Operational 
Investigation 
Committee of Zambézia 
(NIOZ) 
Technical oversight 
Sara Van Rompaey 
FGH 
Quality Improvement 
Advisor 
Co-Investigator 
Caroline DeSchacht 
FGH 
Director of Evaluations 
Technical oversight; support of 
HoPS+ Study manager 

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Lazaro Calvo 
FGH 
Impact Assessment & 
Program Evaluation 
Director 
Technical oversight for surveys 
and ethics trainings 
Fernanda Alvim 
FGH 
Director, Monitoring and 
Evaluation 
Data Quality Monitoring 
Focal person TBD 
FGH 
HoPS+ Study Manager 
Coordination and supervision of 
study 
Erin Graves 
VUMC 
Program Manager 
Technical and administrative 
oversight 
Carolyn Audet 
VUMC 
Principal Investigator 
Technical oversight and 
mentoring 
Heather Jordan 
VUMC 
Program Manager 
Finance and technical support 
  
 
4. Introduction and Justification 
Poor PMTCT Treatment Retention among Women in Mozambique 
Mozambique has one of the world’s highest HIV/AIDS burdens, and is the home of one of the 
world’s poorest and most medically underserved regions, Zambézia province, located in north-
central Mozambique (Fig.1). Adult HIV prevalence in 2009 was 12.6%, but among pregnant 
women was substantially higher (estimated 20%-28%).[1] According to the 2011 Demographic 
and Health Survey, 74% of pregnant women in Zambézia attended at least one prenatal visit.[2] 
In our 2014 unpublished Presidents Emergency Plan for AIDS Relief (PEPFAR) program data, 
81% of pregnant woman who came to the antenatal clinic (ANC) were tested for HIV, but only 
80% of them initiated antiretroviral therapy (ART). Half of HIV+ pregnant women abandoned 
care within six months of ART enrollment. Fewer than 40% returned with their infants for Early 
Infant Diagnosis (EID) services. Among returnees, only 70% of infants received a PCR test to 
determine HIV status and only 30% of HIV-infected infants were enrolled on ART (unpublished 
data, FGH-Zambézia). Thus, only 2% of women received all steps of the cascade necessary for 
PMTCT, probably the lowest program coverage rate in all of sub-Saharan Africa.  
In Mozambique, all HIV-infected pregnant women are now eligible for life-long antiretroviral 
therapy (ART), regardless of CD4+ cell count (Option B+).[3-5] However, retention in care 
among women enrolled through Option B+ programs remains sub-optimal in sub-Saharan Africa 
(SSA) [6-8] primarily due to the need for male partner approval to access health services.[9] 
Poor medication adherence in Option B+ programs increases risk of mother-to-child 
transmission and ART resistance.[10, 11] In 2012, there were 94,000 HIV-positive pregnant 
women in Mozambique.[12]  PEPFAR implementer, Friends in Global Health data indicated 
8.0% of all pregnant women were HIV-positive; 60% had HIV-infected partners in 2014.[9] 
Eighty percent of HIV-infected pregnant women and <10% of HIV-infected partners identified 
during antenatal care (ANC) enrolled on ART. Retention was abysmal: 50% of women and 88% 

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of men abandoned care within six months (FGH M&E data). At one year, 8% of exposed infants 
in Mozambique were HIV infected vs. only 1.8% in neighboring South Africa.[13, 14]  
Role of Male Partners in Retention and Adherence to HIV Health Services 
Women have identified a lack of support from husbands or male partners as a principal barrier 
to engagement in ANC and HIV testing services.[15-17] Qualitative[16, 18-20] and clinical 
data[21] across SSA reveal that women are reluctant to accept HIV testing and treatment if their 
partners are unsupportive, highlighting the importance of partner engagement and 
programmatic adjustment to prevailing social gender norms. Our HoPS evaluation revealed that 
a male partner is the most influential family member affecting a woman’s health decisions in 
rural Mozambique.[22] Yet long-standing community norms inhibit men from engaging in the 
prenatal care of wives or partners.[23] Mozambique is not unique: socially acceptable 
engagement of male partners in HIV counseling during ANC has also resulted in increased 
acceptability of testing and treatment uptake across SSA.[24-32]  
Integrating Male Partners to Improve Treatment Adherence 
By engaging the HIV-infected male partner, we can address multiple patient-reported barriers to 
retention in care in rural Mozambique, notably partner support, transportation and security while 
traveling to and from the health facility, and disbelief or denial of the HIV diagnosis by family 
members.[33, 34] In addition, the couple becomes a de-facto adherence groups.[35-38] 
Including partners in medical treatment improves patient retention by creating an accountability 
and support triad: a patient’s commitment to treatment is enhanced when both the partner and 
provider offer support.[22] In addition, partners exist in one’s lived environment. Through the 
provision of partner-based ART services, adherence to treatment becomes entwined with lived 
experiences rather than messages only delivered when at clinic. Thus, to achieve elimination of 
mother-to-child transmission (EMTCT) and improve the health of HIV-infected couples, 
innovative strategies to engage HIV-infected male partners in ANC are essential.[18, 19, 26, 27, 
39, 40],[41-44]  
Our proposed research builds on a 4-year pilot intervention that developed a community-based 
strategy to engage male partners in the ANC services of their wives in rural Mozambique. 
Homens para Saúde (HoPS) – (“Men for Health”), deployed respected men as community 
health workers and Traditional Birth Attendants (TBAs) to provide community-based counseling 
and accompany couples to ANC/HIV testing, and led to substantially improved service uptake 
within two years. In our new project, “HoPS+”, we will implement a novel partner-based ART 
enrollment immediately when both partners receive simultaneous HIV diagnoses in ANC. 
Our intervention will create an integrated structure to provide couple-based ART within 
comprehensive HIV care and treatment services. Anchored on professional and peer couples 
counseling, this intervention will ensure that partners are engaged and retained in care 
throughout pregnancy and the post-partum period. 
 
5. Objectives 
The overall goal of this project is to develop and assess the impact of a partner-based ART 
delivery intervention among HIV-positive expectant couples.  
 
Our specific objectives are as follows: 

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Objective 1:  To implement, monitor, and evaluate the impact of couple-based services 
on retention in care, viral suppression, and early infant diagnosis (EID) among HIV+ 
pregnant women and their HIV+ male partners through a cluster RCT. Implementation 
process variables will be collected (number of expert-couple counseling sessions, adherence to 
content, and evaluation of participant and peer experiences).   
  
Objective 2: To investigate the impact of the HoPS+ intervention on hypothesized 
mechanisms of change.  
We will determine the intervention’s impact on hypothesized mechanisms of change, including 
(1) partner social support;[45] (2) HIV stigma;[46] (3) relationship empathy [47](4) HIV 
knowledge;[48] and (5) patient trust in provider[49] through quantitative surveys with patients at 
baseline and 6 months.  
 
Objective 3: To use validated simulation models to evaluate cost-effectiveness of the 
HoPS+ intervention. 
This study is important because it targets the health and well-being of the mother-infant-male 
partner triad,[50] the essential family group that has eluded effective engagement strategies in 
HIV care. It builds on our research team’s extensive experience in: (1) HIV care and treatment; 
(2) male partner engagement; (3) and cost-effectiveness analysis. Our results will improve 
outcomes by effectively engaging couples in HIV care and treatment during pregnancy and 
beyond. Without effective innovation in culturally appropriate adherence support to all stages of 
the care continuum, EMTCT efforts will fail in rural Africa. 
6. Design and Study Questions 
We propose to conduct a matched-pair cluster Randomized Controlled Trial to evaluate the 
effects of our intervention. To our knowledge, this is the first ANC-based couples study that will 
assess definitive treatment outcomes within a randomized controlled trial (RCT), and analyze 
the cost-effectiveness of the intervention. Twenty-four primary and secondary level health care 
facilities in Zambézia Province will be matched and then randomized to the control (standard-of-
care [SOC]) or intervention (HoPS+) arms (12 sites per arm). We opted for a study design in 
which the unit of randomization is the EMTCT clinic (not the individual) because it would be 
extremely difficult to implement the intervention to only a subset of clients within each facility. 
We will match clinics on ART uptake rates, retention in care among patients on treatment, 
patient volume, HIV prevalence in ANC, and level of facility (secondary or primary)[51] using 
reweighted Mahalanobis distances[52] and then randomize clinics in each matched pair to 
intervention and SOC arms – 12 clinics per arm, 24 total. Intervention and control sites will be 
>100 km of each other to prevent contamination.  
 
There are four specific study questions:  
Question 1: Is our intervention idea (partners-based ART services for expectant and post-
partum couples) acceptable to expectant couples? 
Question 2: Does our intervention positively impact partner support for ART medication 
adherence and retention in care? Does it increase empathy among partners enrolled? Does it 
increase knowledge about HIV? Does it reduce HIV stigma among couples enrolled into the 
intervention? 

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Question 3:  Does our intervention improve the proportion of exposed infants who are tested for 
HIV (early infant diagnosis)? Does it decrease the number of infants who are HIV-positive at 12 
months? 
Question 4: Is the intervention cost-effective? Would the Ministry of Health be willing to scale it 
up based on our costing data?   
7. Study Population 
 
a. Population:  
Couples consisting of two adults 18 years or older (one HIV-infected pregnant woman and her 
HIV-infected male partner) presenting for ANC services together at one of 24 clinical sites in 
Zambézia province.  
b. Inclusion Criteria:  
Couples, one HIV+ pregnant woman and her infected male partner, will be eligible to participate 
if the woman’s due date is >2 weeks from enrollment. Both persons must also be 18 years or 
older, able to give consent, willing to consent to an infant record search, and must agree to 
enroll in ART together.  
c. Exclusion Criteria: 
Couples will not be eligible to participate in the study if the woman is not pregnant, if both 
persons are not HIV+, if either person is younger than 18 years, if one member of the couple is 
unwilling to enroll in ART or consent to the infant record search, or if one member of the couple 
is unable to give consent due to mental limitations. 
d. Calculations of Sample Size:  
Objectives 1 & 3: With 24 clusters and 45 couples per cluster, we have over 80% power to 
detect a 30% increase in the proportion of pregnant women who initiate ART from 55% to 
71.5% with α = 0.05.  Our power calculations count adults and babies who dropout during 
the EMTCT cascade (e.g. do not initiate ART) as failures for downstream aims (e.g. 
retention on ART or viral suppression). For example, SOC ART retention was calculated as 
the proportion of women who initiated ART multiplied by the proportion of women retained in 
care (0.55×0.56=0.31). In our sample size calculation, we power for a 20% increase in adult 
ART retention (above and beyond the 30% increase in adult ART initiation, for an 
improvement in retention from 31% to 48%), 90% vs. 80% viral suppression among women 
or men, 20% increase in EID testing, and 40% reduction in infant HIV positivity.  Women, 
men and infants will be evaluated as separate study populations. 
Objective 2: Aim 2 analyses will utilize a subset of the 1,080 enrolled couples (2,160 
individuals) who are alive and can be contacted to provide data by 6 months after 
enrollment, regardless of whether or not they are retained in care. Because the psycho-
social data collected by 6 months may be influenced by whether or not participants were 
retained through 6 months, our analyses will initially only consider retention outcomes after 
6 months to maintain the temporal order needed to infer any mediation effects. 
 

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e. Sampling 
 
Participants: HIV infected couples will be enrolled for 6 months at each study site. Patients will 
be enrolled on a first come, first enrolled basis until 40 couples have been enrolled. 
 
f. 
Patient participant retention and withdrawal: 
As per standard clinic procedure, couples on the control arm will receive separate clinical 
services at the ANC building and the adult HIV clinic, respectively. Peer educators will track all 
clients who miss appointments at control and intervention sites. The Home Based Care workers 
will document clients as terminating care if they: (1) discontinued services due to death; (2) 
transferred their care to another clinic that is not in the study; (3) are lost to follow-up (defined as 
being >90 days late for a clinic appointment plus 3 failed attempts at tracking the client); or (4) 
discontinue for any other reason, including patient choice. Clients will not receive any 
remuneration for participating in the study, per Mozambican National Medical Ethics Committee, 
but interview participants will be provided a small snack. Clients will be allowed to discontinue 
participation and may decide that their medical data cannot be used in the analysis at any time 
during the study. 
 
8. Methods 
 
a. Study Procedures 
Couples in the intervention and SOC arms will be consented into the study immediately after 
testing positive for HIV through couples counseling at an ANC appointment. Enrollment will be 
completed by a study assistant based at the site. A similar enrollment protocol in Zambézia has 
yielded study enrollment >95% 
immediately after an HIV test is 
completed; so we anticipate few 
recruitment problems. Patient 
management and monitoring forms will 
be completed for all HIV-infected 
couples enrolled in the study. Select 
demographic, clinical and laboratory 
data from these forms will be routinely 
entered into the OpenMRS electronic 
medical record system (EMR) at FGH-
supported sites. OpenMRS data are 
managed by the FGH data manager who 
identifies discrepancies, works with sites 
to resolve them, and updates the 
database accordingly.[53] 

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Figure 1: Procedures in Standard of Care vs. 
Intervention 
Standard-of-care services (SOC) (Objectives 1 & 2): 
The 12 clinics randomized to the control arm will continue to provide SOC EMTCT services 
that include: standard HoPS male engagement (male invitation to ANC services and couples 
HIV testing), opt-out rapid HIV testing of all pregnant women attending ANC, HIV-specific 
counseling and support for all women 
who test positive, provision of 
cotrimoxazole prophylaxis, and universal 
ART, as per option B+ guidelines (Figure 1).[4] Couple as well as relevant medications are also 
offered free of charge in the HIV clinic to male partners. Post-partum women and their exposed 
infants continue EMTCT follow-up, after delivery, at the EID clinic in a “one-stop point of care 
model”. Post-partum women continue their HIV care and treatment follow-up, including provision 
of cotrimoxazole prophylaxis, and counseling and support; infants have access to HIV testing by 
dried blood spot (DBS)-PCR as early as 4-6 weeks after birth,. Follow-up at the EID clinic for 
both mother and infant continues for 18 months, unless an infant is diagnosed HIV positive and 
referred to HIV treatment services (Table 2).  
Intervention arm: “Homens para Saúde +” (HoPS+) – (Men for Health+) (Objectives 1 & 2): 
The 12 clinics randomly assigned to the intervention arm will receive a combination of 
community and clinical EMTCT services, including: (1) ANC-based couples HIV testing, 
couples-based treatment enrollment, and care for sero-concordant HIV+ expectant couples; (2) 
couple-centered treatment in the post-partum period at the EID clinic; (3) couples-based 
education and skills building during the ANC and post-partum period; and (4) treatment 
continuity support by expert-patient (peer) navigators selected among couples who have 
successfully navigated EMTCT (Figure 4).[27, 31, 54, 55] 
Couples education and skill development- HIV+ expectant couples will receive six 
counseling and skill development sessions throughout the ANC and post-partum period (every 
other month) to provide a venue for couples to: (1) share thoughts and feelings about their HIV 
diagnosis; (2) make decisions related to HIV care and treatment; (3) discuss relationship issues 
that emanate from HIV; and (4) discuss relationship issues unrelated to HIV.[56] Couples may 
experience the process of HIV treatment differently than those enrolled individually. For 
example, one partner may constantly seek the other partners point of view (with positive or 
negative impact), there may be verbal, physical or sexual abuse, or one person may disclose 
information without the others consent. Providing skills to navigate the inherently complicated 
process of couple-based treatment is essential to retention and adherence.[57, 58] Based on an 
adaption of the “PREP approach”, counselors will be trained in cognitive-behavioral marital 
therapy and communication –oriented marital strategies, to help couples maintain high levels of 
function and prevent marital problems from developing (Appendix 1: Curriculum description). 
These sessions will be provided by a trained couple’s counselor (already in place) at the clinic.  
Expert Peer Couple Partner- Couples will be matched with an expert peer couple trained to 
deliver couple-based adherence support (based on the Adherence Support Worker 
program)[59] who have successfully completed the PMTCT cascade in the past two years 
(since Option B+ was initiated). Couples will be eligible to act as expert peer couples if they are 
both living with HIV, the male partner attended at least one ANC appointment and the mother 
was retained in HIV care 9 months post-partum. Couples will have the opportunity to choose the 
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a 2km radius of their community. This peer-mentorship will begin the first week of enrollment; 
monthly meetings (at an agreed upon location in the community) will be held until infant 
prophylaxis is complete (~ 9 sessions). Peers will discuss their own experiences with PMTCT 
services, provide community-based advice if the couple experiences adverse effects of ART, 
and help the couple deal with the social stigma, specifically enacted and internalized stigma 
related to HIV. Matching the newly diagnosed HIV-infected couple with “expert peer support” by 
another couple that has successfully navigated the PMTCT cascade will provide two essential 
components of quality care, including provider continuity and community-based peer support. 
Continuity of care has been traditionally assessed based on clinical measures of provider 
continuity.[60-62] We propose to improve this model by adding a level of continuity of care at 
the community level. In Mozambique there is a history of patient-provider conflict and 
distrust.[34, 63] We believe that expert peer support will help address this barrier to quality care 
by allowing personal testimony from peer participants of how PMTCT care affected their health 
and that of their infant. In addition to ensuring continuity of care, expert peer partners can 
provide community-based support for couples enrolled in PMTCT services. HIV stigma remains 
a significant barrier to retention in care and adherence to ART.[64, 65] These experts have 
navigated this social reality and can provide advice, assurance, and support if couples perceive, 
experience, or internalize HIV-related stigma.[46, 66-70]  
 
Cost-effectiveness Analysis (Obj. 3): 
We will use detailed models of HIV in women, their partners, and children to project the long-
term clinical outcomes, costs, and cost-effectiveness of the HoPS+ program. We will link 3 
published, validated models to simulate a cohort of mother-father-infant pairs throughout 
pregnancy, breastfeeding, and their lifetimes: 1) a decision analytic model simulating a cohort of 
women through pregnancy and delivery (the “MTCT model”);[71-73] 2) a model of HIV disease 
among postpartum women (the “CEPAC-Adult model”);[74, 75] and 3) a model of perinatal and 
postpartum HIV infection (the “CEPAC-Pediatric model”).[76, 77]  
To inform cost inputs related to the HoPS+ program during the study period (ANC enrollment 
through 12 months postpartum), we will collect data on healthcare and non-healthcare RU for 
both the SOC and HoPS arms. These will include number of clinic, laboratory, and pharmacy 
visits, as well as inpatient admissions and length of stay. We will gather data on patient time and 
costs, including days missed from usual activities, such as work, school, or housework, for 
illness; time spent attending clinic visits; time and costs of transport to clinic visits; and costs of 
childcare and food/beverages during clinic visits or counseling sessions. We will ask patients 
about formal and informal work, and costs will be assigned to patient time based on missed 
wages. To include program and provider costs, we will collect data on the provider time required 
to implement the interventions, as well as to lead or undergo training. Costs will be assigned 
based on average salaries. Additional intervention costs, such as transport costs for home 
visits, will also be included. For longer-term projections (5-year, 10-year, and lifetime), we will 
use published data on HIV-related healthcare resource utilization and costs.[78] We have 
derived these data for adult HIV care with collaborators in Mozambique, and we will use a 
similar approach to derive HIV care costs for children.[75]  
 
b. Measurement of Results 

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Objective 1: Routinely collected demographic, community-based social support, and HIV care 
and treatment data will be used in the analysis. Select demographic, clinic, and laboratory data 
from these forms are entered routinely into OpenMRS (an electronic medical record “EMR” 
system) at FGH-supported sites. 
Objective 2: Individuals consented in the study will complete interviewer-assisted, quantitative 
study measures at baseline and by 6 months post-study enrollment, including measures of: 1) 
partner social support;[45] (2) HIV stigma;[46] (3) empathy [47]; (4) HIV knowledge;[48] and (5) 
patient trust in provider.[49]  
Objective 3: Clinical outcomes of the linked models include MTCT risk at birth and weaning, 
pediatric life expectancy from birth, maternal and paternal life expectancy from presentation to 
care, and combined (maternal + paternal + pediatric) life expectancy. Economic outcomes, from 
the healthcare system perspective, include antenatal and postnatal program costs, lifetime 
maternal HIV-related healthcare costs, lifetime pediatric healthcare costs, and 1 to 5-year 
maternal and pediatric health care costs. We will use these outcomes to calculate incremental 
cost-effectiveness ratios (ICERs) in $/life-year (LY) as the difference in combined healthcare 
costs (program + maternal lifetime + paternal lifetime + pediatric lifetime costs) between the two 
strategies, divided by the difference in combined projected life expectancy (maternal + paternal 
+ pediatric life expectancy). For ICERs, all outcomes will be discounted at 3%/year.[79-81] We 
will consider a strategy to be "cost-saving" if it leads to greater combined life expectancy and 
lower combined costs than an alternative strategy. Following WHO guidance and evolving 
consensus in the field of cost-effectiveness analysis, we will consider a strategy to be "cost-
effective," compared to its alternative, if its ICER is <0.5-1.0x Mozambique per-capita gross 
domestic product (GDP: $525 in 2015)/LY. Recognizing the limitations of this approach, we will 
also compare ICERs to other HIV interventions in Africa, e.g., first line ART ($500-
$5,500/LY).[82-86] 
The primary data from the HoPS+ program (Objectives 1& 2) will be used as inputs to the MTCT 
model. These data will include the proportion of mother-infant pairs accessing each step in the 
EMTCT cascade under the HoPS+ and SOC service-delivery models: ANC, HIV testing, HIV 
test results, offer and receipt of ART, viral suppression, delivery in a healthcare facility, and 
linkage to maternal and pediatric care (including EID) after delivery. Data reflecting the biology 
of HIV infection, including MTCT risks and HIV disease progression (stratified by CD4 and ART 
use) will be derived from published data, as in previous work,[71] and will be primarily 
incorporated into the CEPAC-Pediatric and Adult models. We use published data to inform 
these parameters because EID and ART program data are limited by small patient numbers and 
by differential loss to follow-up (i.e., higher MTCT, disease progression, and death among those 
lost to care). 
Cost inputs to the models are derived in two steps. First, we estimate healthcare and non-
healthcare resource utilization (RU), including inpatient days, outpatient visits, laboratory and 
pharmacy, and patient and provider time. Next, we assign a unit cost to each resource used 
(e.g., cost per inpatient day, or wages per hour of provider time), and calculate total costs as the 
product of RU*unit cost.[79] 
 
c. Instruments used in the study 

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We will use the following instruments in the study: (1) partner social support;[45] (2) HIV 
stigma;[46] (3) empathy scale [47] (4) HIV knowledge;[48] and (5) patient trust in provider[49] 
(see Appendix 2). These instruments are quantitative scales, which provide closed ended 
options for patient response. We will also utilize the Patient Health Questionnaire (PHQ-9) 
depression screening tool [87] with all participating adult patients (Appendix 3). This 
instrument is also a quantitative scale with closed ended response options; scores collected at 
baseline and 6 months will be used as covariate variables in data analysis (see Section 10). 
 
d. Anticipated end date of study: 
 
This study is expected to be concluded in June 2022. 
 
9. Locations of Study 
Friends in Global Health supports HIV care and treatment services to 88 clinical sites in the 
province. Our trial will involve 24 of these clinics. These sites range from small district-level 
hospitals to rural health posts. All provide Option B+ services free of charge to HIV-infected 
pregnant women and their partners. In 2015, FGH clinics tested 95% (114,857) of the pregnant 
women presenting for ANC for HIV and provided Option B+ ART services to 87% (8,137 newly 
diagnosed women); 3,000 HIV-infected men were identified through ANC-based couples 
counseling.   
Table 2: Study Sites by intervention Status 
 
Intervention sites 
Control sites 
 
Health Facility 
District 
Health Facility 
District 
1 
Muiane CS III 
Gilé 
Mocubela CS III 
Mocubela 
2 
Mixixine CS III 
Namacurra 
Inhassunge CS I 
Inhassunge 
3 
Palane-Mucula CS II 
Inhassunge 
Mugubia CS  
Namacurra 
4 
Gurai PSA 
Mocubela 
Bingagira PS 
Inhassunge 
5 
Muebele PS 
Namacurra 
Gonhane CS III 
Inhassunge 
6 
Maganja da Costa CS III 
Maganja dC 
Gilé CS II 
Gilé 
7 
Naburi CS III 
Pebane 
Tapata CS III 
Mocubela 
8 
Nante CS III 
Maganja dC 
Malei PS 
Namacurra 
9 
Tomeia PSA 
Pebane 
Pebane CS II 
Pebane 
10 
7 de Abril CS III 
Pebane 
Magiga PSA 
Pebane 
11 
Pele-Pele CS 
Pebane 
Alto Maganha CS 
Pebane 
12 
Madal CS 
Quelimane 
M'Baua CS III 
Namacurra 
 
 
 
10. Data Management and Analysis 
Data Management and Security 

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The data collected will be kept in a database housed in Mozambique. Data will be stored in a 
restricted access folder that sits on the FGH server. In addition, data will be password-protected 
to limit access to staff involved in the study and to ensure confidentiality. Data will be encrypted, 
backed up on FGH servers, and uploaded to the Vanderbilt servers as needed for PI access.   
FGH servers have daily backups scheduled; therefore, all data will be backed up on a day-to-
day basis. 
 
Data from the surveys will be coded and transferred into a REDCap database by field staff 
trained in data entry. The original surveys will be locked in a file cabinet in the FGH office in 
Quelimane for 5 years. Only the PI and Study Manager at the FGH Quelimane office will have 
access to the coded data. The data files will be password-protected to ensure confidentiality. All 
routine monitoring data will be documented by health facility staff into patient clinical records.  
Data are extracted from patient clinical records into electronic patient tracking systems already 
established and functioning as part of routine monitoring by FGH data entry specialists. The 
staff has specific training on data confidentiality; all FGH staff sign confidentiality agreements as 
they come into contact with patient clinical files. 
 
With the initiation of expanded HIV care in Mozambique, medical records were implemented 
using standardized national forms and an HIV service card, known as the “Green Card", which 
the patient keeps in order to be identified as part of the service.  As the HIV care program has 
grown, FGH and other PEPFAR partner organizations within the province have implemented 
electronic databases using either ACCESS® or OpenMRS, depending on the district, to collect 
patient information facilitating the maintenance of these records for the Ministry of Health’s 
program.  At the end of each patient encounter, data entry personnel based at the health facility 
enter information collected on the paper forms into the electronic database. This database does 
not have the capacity to collect information from the various different services and connect them 
to a specific patient. As a result, only information from the HIV care is currently collected in the 
electronic database.   
 
The OpenMRS databases are password protected and can only be accessed by FGH 
monitoring and evaluation staff. Data quality assurance for the OpenMRS is ensured through 
semi-annual audits as well as automatic data validation steps. All data are reviewed by FGH 
regional data supervisors at the district level and by data analysis officers based in the FGH 
provincial offices in Quelimane. Corrective measures are taken as necessary as a result of data 
quality audits and regular reviews of data.  
 
For this project, de-identified data will be extracted into a restricted dataset by FGH employees 
from the existing OpenMRS databases and sent to a VUMC Biostatistician for analysis. All 
routine programmatic data are owned by the MOH.  All routine programmatic data are part of 
the clinical record and as such will not be destroyed. 
 
Data Analysis 
Objective 1: Statistical analysis plan for Objective 1. We propose a generalized linear mixed 
effects model, with random effect for clinic.[88] A simple model for E(Yij), the probability of ART 
initiation in the ith clinic at the jth time-point is given by:  
logit E(Yij) = β1 + β2Groupij + bi + eij 
 where bi is a random effect for clinic i which accounts for clustering of patients within clinics, 
due perhaps to similarities in health-seeking behavior and/or access to care. β1 is a fixed effect 

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16 
 
corresponding to time j, Groupij is an indicator of intervention, and β2 is the treatment effect 
(difference in log odds of ART receipt). We test the hypothesis, H0: β2 = 0. The mixed effects 
model will be extended to allow for covariate adjustment, such as: age, education, and distance 
from clinic. Separate models will be used to assess each outcome in each population (men, 
women, infants). For example, ART initiation among pregnant women (n=1,080) and then ART 
initiation among male partners (n=1,080). All adult patient models will include depression scale 
scores as covariates in attempts to control for potential presence of depression symptoms 
among participant groups. Female-specific models allow for inclusion of covariates unique to 
pregnant women, such as prior ANC, parity, etc. We also expect the intervention odds ratio to 
differ between women and their male partners.  For infant HIV infection, sensitivity analyses will 
be conducted to investigate the effect of no EID test result on HIV infection; infants of mothers 
who did not initiate ART or were not retained in care at delivery will be assigned probabilities of 
infection (with definitions based on latest research).  Then, infant HIV status will be multiply 
imputed using the Bernoulli distribution and estimates from the multiple regressions will be 
combined with multiple imputation techniques. An intent-to-treat approach will be employed for 
all analyses.  
Due to the potential for false positive results when many comparisons are performed, we will 
report test results in all abstracts, manuscripts, and presentations in a pre-determined order as 
ascertained by the HoPs+ investigators. For example, the order of reporting results could be 
male initiation, male retention, female initiation, female retention, etc.; the final order will be 
selected a priori. Because we are interested in answering multiple questions but will report all 
analyses in the context of the aforementioned ordering, no adjustment for multiplicity will be 
performed, an approach consistent with recommendations for clinical trials.[89] Analyses will be 
conducted using R software (www.r-project.org), and scripts will be accessible on our Vanderbilt 
project website. 
Objective 2: Generalized linear mixed effects model will be utilized as described for Objective 
1, replacing the logit transformation of the outcome with an untransformed linear outcome 
because the outcomes are continuous. Intervention status remains the exposure variable of 
interest and β2 is the treatment effect (difference in mean levels of knowledge, stigma, etc.). As 
with Objective 1, gender specific models will be used to model each outcome of interest, 
adjusting for individual level covariates such as age, education, depression scores, and distance 
from clinic. Interactions between intervention status and the baseline value of each endpoint will 
be used to assess for modification of the intervention effect. All potential mediators found to be 
associated with the intervention at p<0.20 in Objective 2 will be included in a multi-level 
structural equation model (SEM) to account for clustering within clinics (Figure 2). SEM is well-
suited to examining mediating and moderating processes over time [90-94]. Specification of the 
potential mediators as latent variables in 
SEM allows for better specification of 
measurement error, potentially reducing 
bias.[91, 94] Further, the capacity to 
detect and adjust for potential reporting 
bias in key study measures (e.g., does 
social desirability lead male partners to 
systematically report lower stigma) 
ensures that true differences in 
parameter estimates are not inflated by 
Figure 2: Mechanisms of Intervention Effect 

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17 
 
reporting bias.[95] Specific to this objective, SEM yields precise estimates of mediating and 
moderating relationships that adjust for the presence of all other variables in the model, more 
precisely capturing the complex reality of these processes. Direct (including controlled and 
natural), indirect (including natural), and total effects of the intervention through the mechanisms 
identified in Aim 2a will be estimated. Further, SEM allows for the flexible respecification and 
modeling of alternative mediating pathways, such as whether improved levels of social support 
may be associated with reduced stigma, which is in turn predictive of retention.[94] It also allows 
for exploring the impact of omitted variables, providing a post-hoc estimate of how robust the 
parameter estimates are.  
Objective 3: The MTCT model is a simulation model of a cohort of pregnant women, from the 
time of conception through delivery. The model is a deterministic model, with a decision-tree 
structure, coded in TreeAgePro® software (Williamstown, MA); validation and sensitivity 
analyses are published.[72, 73, 96-98] Modeled events include the key steps in the EMTCT 
"cascade of care:" presentation to ANC; offer and acceptance of HIV testing; receipt of HIV test 
results; offer of, acceptance of, and adherence to ART; maternal mortality during pregnancy; 
HIV testing in labor for women with unknown/negative HIV status; live birth; infant HIV infection 
at delivery; and linkage to postnatal care and ART for mothers and infants.[99] After delivery, 
model outcomes for infants include vital status and HIV infection/exposure (infected, exposed-
uninfected, or unexposed); model outcomes for mothers include vital status, CD4 (> or ≤350/µL) 
and current ART receipt. These outcomes at the time of delivery are translated into long-term 
survival, life expectancy, and costs by simulating the lifetimes of mothers, fathers and infants in 
the CEPAC models. 
The CEPAC-Adult model is a first-order, patient-level (Monte Carlo) simulation of adult HIV 
infection. People with HIV are simulated individually from delivery through death, and HIV 
disease progression is characterized by monthly health state transitions. Health states include 
acute opportunistic infections (OIs), chronic HIV infection, and death. Monthly risks of OIs and 
HIV-related death are estimated by CD4 count, OI prophylaxis and history of OIs, and 
availability of and response to ART. The model uses clinical events and monthly costs over 
each patient's lifetime; model outcomes include average per-person costs and life 
expectancy.[74, 100-102]  
The CEPAC-Pediatric model is a Monte Carlo simulation of HIV infection in children, calibrated 
to African settings.[76] Infants enter the model at birth. HIV-uninfected infants face a monthly 
risk of postpartum infection if breastfed. Infants with in utero, intrapartum, or postpartum HIV are 
assigned an initial CD4% and HIV RNA level. Disease progression follows monthly transitions 
among health states as for adults, and these transitions are dependent upon current 
CD4/CD4% and age.[103] Each ART regimen confers a probability of suppressing HIV RNA to 
<400 copies/ml, which leads to an increase in CD4% or CD4 and a reduced risk of OIs and 
death. ART failure can occur at any time, and simulated patients can be switched from first- to 
second-line ART after observed clinical, immunologic, or virologic failure. Model outcomes 
include survival and costs, as for the adult model. The CEPAC website 
(http://web2.research.partners.org/cepac) provides details of the CEPAC-Pediatric and Adult 
model structures. 
 

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18 
 
11. Ethical Considerations 
The sites that participate in this proposal meet the requirements for the conduct of research 
using funds from the US Government.  The protocol and consent forms will be reviewed and 
approved by the Vanderbilt University IRB (FWA00005756, IRB00000475-7, IRB00002125) and 
the Ministry of Health in Mozambique (FWA00003139 IRB# IRB00002657). The proposed 
project is Non-Exempt Human Subjects Research. 
Recruitment and Consent of HIV+ Couples: Couples who test positive for HIV during an ANC 
visit at one of the study sites will be asked a whether they would be willing to participate in a 
research study. If the couple is interested, they will be provided a consultation with the study 
coordinator, at which point they will be asked to give informed consent through our consent 
form. This consent will include their willingness for us to access medical records and participate 
in survey sessions.  
 
Participant confidentiality 
 
All participants who are consented in the study will be assigned a study ID number. Only study 
members will have the codebook that links the identifiers. Identifying information associated with 
these ID codes, such as names, will be kept in a data file separate from the survey data and 
clinic records. All data will be managed in a way that meets Vanderbilt IRB and Mozambique 
Bioethics standards for the protection of human subjects and to ensure confidentiality and the 
protection of sensitive health information. 
 
A participant’s study information will not be released without the written permission of the 
participant. All study-related information will be stored securely at the study site. All participant 
information will be stored in locked file cabinets in locked rooms, i.e., access is limited to study 
staff. All study data collection, process, and administrative forms and other reports will be 
identified by a coded number to maintain participant confidentiality. All records that contain 
names or other personal identifiers, such as locator or informed consent forms, will be stored 
separately from study records identified by a code number. All databases will be secured with 
password-protected access systems. Forms, lists, logbooks, appointment books, and any other 
listings that link participant ID numbers to other identifying information will be stored in a 
separate, locked file in an area with limited access.   
 
Consent Procedures  
 
The consent procedures are detailed above and the consent form can be found in the annex 
(Appendices 4 and 5). The signed consent forms will be kept in a lock box at the FGH office in 
Quelimane, separate from the transcripts of the interviews. The consent forms will be kept for 7 
years, at which point they will be burned to ensure that no one will be able to link any consents 
to participants.   
 
Evaluation of benefits and risks 
 
Adverse events  
 
Risks to the subjects (both intervention and control group): The level of risk associated with this 
research is expected to be minimal for all participants. Potential psychological discomfort may 
occur when administering the survey as many of the questions are personal and have to do with 

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19 
 
a stigmatized infectious disease. Participants are able to decline to answer any question that 
they deem uncomfortable.  
 
Participants who enroll in couples HIV care and treatment will have the potential for inter-
personal conflict, given that they will receive their care and treatment together. To mitigate this 
concern we are providing couples based counseling at the facility and peer support in the 
community.  
 
Adverse Experience: We do not anticipate any adverse events as a result of this study, however 
study participants will be provided with a telephone number and instructed to contact study 
clinicians to report any serious AEs they experience.    
 
Protection against risks: The study protocol and training manuals will include strict guidelines for 
conducting the survey and recording the data in a confidential manner. All study staff will 
receive formal responsible conduct of research training per NIH, Vanderbilt, and Mozambican 
Ministry of Health guidelines. Participants may withdraw from the study for any reason at any 
time. 
 
Benefits 
For HIV-infected couples there is a possibility that couple-based HIV care and treatment will 
result in them gaining additional psychosocial support and education for their HIV treatment.  
For these patients, they could experience improved health outcomes. The results of this 
evaluation may help us to offer better services for HIV-infected couples living with HIV who 
access services at the study clinics and throughout Mozambique. This could benefit 
Mozambican society through improved health programs for people living with HIV. 
 
12. Limitations  
 
Given the cluster RCT design, inter-clinic contamination is possible but will be eliminated by 
selecting geographically isolated clinics >1.5 hour driving distance apart where patients very 
rarely visit both clinics.  
 
 
13. Dissemination Plan  
Results from this study will be collected into a report, and will be shared with MISAU and the 
DPS.  The results will also be disseminated to government officials and physicians working in 
these communities.  If results are deemed by the authors to be potentially of interest to a wider 
scientific audience, we would plan on sharing these data in manuscript form, after obtaining 
appropriate clearances. 
 
 
14. Budget 
 

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20 
 
Description 
TOTAL 
USD         MZM 
Study Details 
Human Resources 
60,000 
4,200,000 
Price per 
unit/person 
Number of 
people/units  
Project Officer (TBD) 
30,000 
2,100,000 
30,000 
1 
Study Assistants 
30,000 
2,100,000 
1,250 
24 
 
 
 
 
 
TRAVEL & TRANSPORT 
14,670 
 1,026,900 
  
  
maintenance for car/gas 
(per day 44USD) 
6,750 
 472,500  
$45 
150 
cell support for study 
assistants 
2,880 
 201,600 
10 
24 
basic nokia phone for 
each study assistant 
960 
 67,200  
40 
24 
bicycle repair kit 
720 
 50,400  
30 
24 
bicycles for peer 
supporters 
3,360 
 235,200  
140 
24 
  
 
  
  
  
TRAINING/PROJECT 
ACTIVITIES 
5,980 
 418,600 
  
  
Training for Peer 
supporters  
 
  
  
  
    per diem (food) 
2,880 
201,600  
15 
96 
     Venue hire 
1,100 
 77,000  
50 
12 
     Training Materials 
2,000 
 140,000  
2,000 
1 
 
 
 
 
 
OTHER 
2,500 
 175,000 
  
  
Laptop and accessories 
for Project Officer plus 
internet via movital 
2,000 
140,000  
140,000 
1 
Photocopies of consent 
forms and questionnaire  
500 
35,000 
0.25 
 
 
 
 
 
 
Total of all costs 
83,150 
5,820,500 
  
  
Contingency 10% 
8,315 
582050 
  
  
TOTAL  
91,465 
6,402,550 
  
  
15. Timeline 
 
  
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 

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21 
 
 
 
 Study Activities 
1 
2 
1 
2 
1 
2 
1 
2 
1 
2 
Staff and counselor hiring and (re)-training  
 
 
 
 
 
 
 
 
 
 
Enrollment of pregnant women & partners 
  
  
  
  
  
  
  
  
 
 
3, 6 , 12, and 18 month follow up  
  
  
  
  
  
  
  
  
 
 
Survey collection  
 
 
 
 
 
 
 
 
 
 
Fidelity assessments 
 
 
 
 
 
 
 
 
 
 
CEPAC model expansions 
  
  
  
  
  
  
  
  
 
 
Last study participant visits 
  
  
  
  
  
  
  
  
 
 
Data collection & management 
  
  
  
  
  
  
  
  
 
 
Data analysis  
  
  
  
  
  
  
  
  
 
 
CEPAC model inputs from trial data 
 
 
 
 
 
 
 
 
 
 
Model-based cost-effectiveness analyses 
 
 
 
 
 
 
 
 
 
 
Manuscript preparation 
  
  
  
  
  
  
  
  
 
 
Timeline of Study Activities 

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22 
 
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Appendix 1: Couples Education and Training Sessions 
 
Sessions 
Why is this so 
important? 
 
What will couples 
do? 
 
What are the 
results? 
 
1. Personality 
Personality conflicts can serve 
as barriers to healthy 
communication and 
camaraderie—personally and 
professionally. Understanding 
offers a beginning to working 
with different personality types 
more effectively, especially 
when it comes to our primary 
romantic relationship. 
 
 
Unit at a Glance 
 
Lesson 1: Personality 
Differences 
 
Lesson 2: Exploring My Type 
 
Lesson 3: Understanding Our 
Differences 
 
 
Individual Activity: The 
Primary Colors Personality 
Tool 
 
Couple Activity: Discussing 
the Differences in personality 
types 
 
Individual Activity: Looking 
at the Bright Side 
 
Couple Activity: Talking 
about the Positives 
 
 
 
Participants: 
 
• 
Assess their own 
personality for an 
improved sense of 
what individual 
needs they bring to 
the relationship.  
• 
Acknowledge the 
value that each 
different 
personality style 
brings to a 
relationship.  
• 
Explore the 
positives and the 
pitfalls of their 
personality style. 
• 
Practice showing 
appreciation for 
their partner’s 
personality style.   
2. Danger Signs & 
Time Out  
Several key studies indicate 
that patterns of ineffective 
communication-- 
Communication Danger Signs--
can ultimately defeat the good 
intentions of couples by 
negating the feeling of safety. 
 
Chronic negative patterns of 
interaction, in fact, are 
indicators of longevity, strongly 
differentiating happy couples 
from unhappy couples  
Unit at a Glance 
 
Lesson 1: The First Three 
Danger Signs 
 
Lesson 2:  The Fourth Danger 
Sign 
 
Lesson 3:  The Power of the 
Danger Signs 
 
Lesson 4: Time Out 
 
Couple Activity/Skit: What’s 
for Dinner? 
 
Individual Activity: Negative 
Interpretation or Benefit of the 
Doubt? 
 
Couple Activity: Smart or 
Not-so-Smart Time Out? 
 
Individual Homework 
Activity: Creating Your Time 
Out Strategy 
 
Couple Activity/Skit: The 
Power of Humility 
Participants:  
 
• 
Recognize the 
Danger Signs of 
ineffective 
communication.  
• 
Focus on 
minimizing stress 
on each other.  
• 
Replace 
detrimental 
communicative 
habits with 
proactive talking 
strategies. 
• 
Understand the 
value of taking a 
Time Out to 
discourage 
unhealthy 
exchanges. 

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30 
 
 
3. The Speaker 
Listener Technique 
Research strongly indicates that 
when people feel safe enough 
to share their thoughts, as 
opposed to feeling attacked or 
ignored, they are better able 
and willing to talk about their 
issues honestly. The Speaker 
Listener Technique helps 
diffuse the Communication 
Danger Signs that breed 
animosity so that speakers can 
feel safe enough to slow down 
and listen carefully to one 
another. 
 
Unit at a Glance 
 
Lesson 1: What is Good 
Communication?  
 
Lesson 2: The Speaker Listener 
Technique 
 
Lesson 3: Skillful Speaking & 
Listening 
 
Lesson 4: Speaker Listener 
Technique Practice 
 
Couple Activity: What is 
Good Communication?  
 
 
Couple Activity: Practice 
with a Playful Disagreement 
 
 
Couple Activity: Practice 
Sharing a Concern 
Participants: 
• 
Learn and practice 
a proven effective 
model of 
communication—
the Speaker 
Listener 
Technique. 
• 
Reinforce 
Emotional Safety 
through honest and 
open discussion.  
 
4. Events, Issues & 
Hidden Issues 
According to field research, 
couples often repeatedly fight 
about the same Incidents, or 
find themselves sliding into 
major arguments from simple 
beginnings. To avoid the “same 
old argument,” couples often 
fall victim to avoiding talk 
altogether.  
 
Understanding each other is an 
authentic starting point to 
solving the real problems more 
effectively. 
 
Unit at a Glance 
 
Lesson 1: Four Frustrating 
Situations  
 
Lesson 2: The Surface Layer-- 
Events 
 
Lesson 3: The Middle Layer-- 
Issues 
 
Individual Activity: Our 
Events 
 
Individual Activity: Four 
Frustrating Situations 
 
Individual Activity: Our 
Events 
 
Individual Activity: Common 
Issues 
 
Couple Activity: Me? Have 
Hidden Issues? 
 
Couple Activity: Speaker 
Listener Technique for 
Discussing Hidden Issues 
Participants:  
• 
Learn that Events 
often trigger Issues.  
• 
Learn to recognize 
their Issues—from 
past experiences or 
current 
expectations.  
• 
Work on 
discussing their 
Issues, rather than 
letting them be 
triggered by 
Events.  
• 
Experience the 
normalization of 
conflict.  
• 
Learn to flag the 
warning signs of 
Hidden Issues 
disguised as an 
Event. 
• 
Enjoy more 
productive 
discussions that 

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31 
 
Lesson 4: The Core—Hidden 
Issues 
 
can deepen 
intimacy. 
5. Anger & Stress 
Anger & stress factors into our 
relationships from every angle 
of our lives, but romantically, 
stress and anger: (1) drains 
strength, (2) increases conflict, 
and (3) decreases trust. In turn, 
stress wears down our ability to 
give our partners the patience 
and attention they deserve, 
often increasing conflict and 
decreasing trust1.  
 
Unit at a Glance 
 
Lesson 1: The Physiology of 
Stress & Anger 
 
Lesson 2: Two Reasons to 
Manage Amy 
 
Lesson 3: Assessing My Stress 
& Anger 
 
Lesson 4: Strategies to Manage 
Amy 
 
Small Group Activity: AMY 
and Your Health 
 
 
Individual Activity: Assess 
My Stress 
 
Individual Activity: Assess 
My Anger 
 
Group Activity:  The 
Thinking Strategy 
 
Group Activity: The Muscle 
Strategy 
 
Couple Activity: The 
Dealing-with-Stress-&-Anger-
Together Strategy 
 
Participants:  
 
• 
Learn about the 
specific ways that 
stress affects the 
physical and 
emotional well-
being of 
relationships. 
• 
Practice calming 
skills to control 
their own stress.  
• 
Identify ways to 
work as a team to 
deal with stress 
together.  
• 
Improve all 
relationships that 
see conflict/stress-- 
parenting, work, 
sports teams. 
• 
Enact a relaxation 
exercise for 
improved 
awareness.   
 
 
 
 
 
 
 
 
6. Problem Solving 
Most couples are looking for 
healthy ways to solve problems 
together. This unit offers a 
structure that couples can use 
so that they can approach their 
problems as a team. It also 
helps couples set realistic 
expectations that not all 
problems need to be solved in 
order to have a healthy happy 
relationship. The unit 
encourages couples to 
remember to protect all of the 
good stuff in their relationship 
even when problems come up.  
 
Unit at a Glance 
 
Lesson 1: XYZ Statements 
Individual Activity: Practice 
Using XYZ Statements 
 
Couple Activity: Working 
Through the Problem Solving 
Model 
 
Couple Activity: Problem 
Solving Night! 
 
 
Couple Participants:  
• 
Practice talking 
about a problem 
before solving it.  
• 
Identify what 
issues instigate the 
most conflict.  
• 
Engage in 4 steps 
of problem solving. 
• 
Begin to apply 
problem solving 
strategies to their 
own Issues. 
• 
Face productive 
approaches to 
handling 
“unsolvable” 
problems. 

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(For the Small Problems)  
 
Lesson 2: The 4-Step Problem 
Solving Model (For the Bigger 
Problems) 
 
Lesson 3: Managing 
Expectations (For the 
Unsolvable Problems) 
 
 
Appendix 2: Measures used in study 
 
1. Stigma (Van Rie et al. TB and HIV/AIDS stigma scales) 
1.  Some people think that those with HIV are disgusting.  
2. Some people do not want those with HIV playing with their children.  
3. Some people feel uncomfortable being near those with HIV. 
4. Some people do not want to talk with others with HIV. 
5. Some people keep distance from people with HIV.  
6. If a person has HIV, some community members will behave different towards that 
person for the rest of her or her life.  
7. Some people try not to touch others with HIV.  
8. Some people are afraid of those with HIV.  
9. Some people think that people with HIV are unclean. 
10. Some people prefer not to have those with HIV living in their community.  
11. Some people think that people with HIV get what they deserve. 
12. Some people who have HIV feel hurt because of how others react to knowing they have 
HIV.  
13. Some people who have HIV feel alone. * 
14. Some people who have HIV are afraid that other people in the community will talk about 
them having HIV. * 
15. Some people who have HIV lose friends when they share with them they have HIV.  
16. Some people who have HIV are afraid to tell those outside their family that they have 
HIV.  

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33 
 
17. Some people who have HIV worry that others will reveal their secret. * 
18. Some people who have HIV keep their distance from others to avoid spreading the HIV 
virus.  
19. Some people who have HIV feel guilty because their family has the burden of caring for 
them.  
20. Some people who have HIV will chose carefully who they tell about having HIV.  
 
2. Physician Trust (Hall et al. /Measuring trust in Physicians) 
1. Your doctor cares about your health just as much or more than you do.  
2. Your doctor will do whatever it takes to get you all the care you need.  
3. Your doctor’s medical decisions are influenced by how much money [he or she] can 
make.  
4. Your doctor is the kind of person who would fight hard to get your health insurance to pay 
for your treatment.  
5. Sometimes you worry that [your doctor’s] medical decisions are wrong.  
6. Sometimes [your doctor] cares more about what is convenient for [him/her] than about 
your medical needs.  
7. If [your doctor] asked you to be in a medical research study, you would worry that [he or 
she] care more about the research than about what is best for you.  
8. No matter what health problem you might have, [your doctor] will always be able to figure 
out exactly what is wrong.  
9. Your doctor’s medical skills are not as good as they should be.  
10. You think your doctor can handle any medical situation in [his or her] field, even a very 
serious one.  
11. Your doctor does not always give you a chance to say everything you think [he or she] 
needs to know.  
12. Your doctor is extremely thorough and careful.  
13. You completely trust your doctor’s decisions about which medical treatments are best for 
you.  
14. Your doctor will listen with care and concern to any problem you might have, even 
problems that are small or silly.  
15. Your doctor would never prescribe the wrong medication for you.  
16. Your doctor is totally honest in telling you about all of the different treatment options 
available for your condition.  

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17. Your doctor has better medical skills than most other doctors in [his or her] field.  
18. Your doctor sometimes pretends to know things when [he or she] is really not sure.  
19. Your doctor only thinks about what is best for you.  
20. Sometimes your doctor does not pay full attention to what you are trying to tell [him or 
her].  
21. You worry that your doctor may share embarrassing information about you with people 
who have no business knowing it.  
22. Your doctor always uses [his or her] very best skill and effort on your behalf.  
23. You have no worries about putting your life in your doctor’s hands.  
24. Your doctor would never mislead you about anything.  
25. Your doctor is the kind of person who would take care of you even if you could not afford 
to pay.  
26. All in all, you have complete trust in your doctor.  
 
 
3. Empathy 
 
 
 
 
 
 
 
4. Social Support (Berlin Social Support Scales) 
Perceived Emotional Support 
1. There are some people who truly like me. 
2. Whenever I am not feeling well, other people show me that they are fond of me. 
3. Whenever I am sad, there are people who cheer me up. 
4. There is always someone there for me when I need comforting. 
Perceived Instrumental Support 
1. I know some people upon whom I can always rely. 
2. When I am worried, there is someone who helps me. 

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3. There are people who offer me help when I need it. 
4. When everything becomes too much for me to handle, others are there to help me. 
Need for Support 
1. When I am down, I need someone who boosts my spirits. 
2. It is important for me always to have someone who listens to me. 
3. Before making any important decisions, I absolutely need a second opinion. 
4. I get along best without any outside help. (-) 
Support Seeking 
1. In critical situations, I prefer to ask others for their advice. 
2. Whenever I am down, I look for someone to cheer me up again. 
3. When I am worried, I reach out to someone to talk to. 
4. If I do not know how to handle a situation, I ask others what they would do. 
5. Whenever I need help, I ask for it. 
 
5. HIV Knowledge (Ciampa et al/ HIV Knowledge in Mozambique) 
1. HIV and AIDS are the same thing.*  
2. A person with HIV can look and feel healthy.*  
3. A cure for AIDS exists.*  
4. A blood test can tell if a person has been infected with HIV.*  
5. A person who feels sick from AIDS can feel better by taking medicines 
6. A woman who has HIV can give it to her infant during birth 
7. A woman who has HIV can give it to her infant while breastfeeding 
8. A pregnant woman who has HIV can prevent her baby from becoming infected by taking 
medicine 
9. A person can get HIV by getting an injection with a needle that was already used on 
someone else. 
10. A person can get HIV by sharing blades. 
11. A person can get HIV from mosquito bites. 
12. A woman can get HIV if she has sex with a man who has HIV.*  
13. A person can get HIV by sharing forks, spoons or cups with a person who has HIV. 
14. A person with HIV can cure the infection by taking medicine.  

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15. Eating healthy foods can keep a person from getting HIV. 
16. Coughing and sneezing spread HIV. 
17. A person can get HIV by shaking hands with someone who has HIV. 
18. A person can get HIV by a curse. 
19. A person who has HIV can use medicine to prevent becoming sick with AIDS. 
20. A person can seek protection from a traditional healer to avoid getting AIDS. 
21. A man can get HIV if he has vaginal sex with a woman who has HIV. 
22. Bathing or washing one’s genitals after sex keeps a person from getting HIV. 
23. A person cannot get HIV by having oral sex, mouth-to-penis, with a man who has HIV. 
24. Having sex with more than one partner can increase a person’s chance of being infected 
with HIV. 
25. A man wearing a latex condom during sex can lower his chance of getting HIV. 
26. A person with another STD, such as syphilis, is more likely to get HIV. 
27. Cleaning of the vagina with soap before or after sex will keep a woman from getting 
HIV.* 
 
 

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Appendix 3: Patient Health Questionnaire – 9 (PHQ-9)  
 

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Appendix 4: Informed Consent (intervention arm) 
 
This informed consent document applies to adults 18 years or older. This document is to 
be read aloud to the patients in the intervention arm. 
Age of patient: ____________ 
 
Introduction 
This consent form contains information about a new study to provide couples-based HIV care 
and treatment to pregnant couples. This form describes your rights as a participant. It is meant 
to answer your questions. We will read this form to you. Please feel free to ask any questions 
you may have about this.  
If you and your partner agree to participate in this program I will ask you to sign the form or 
make your thumbprint mark. Even if you agree to participate, you can stop participating at any 
time. I will give you a copy of this form. This form might contain some words that are unfamiliar 
to you. Please ask me to explain anything you do not understand. 
 
Purpose of this study  
This study is being done by staff from Vanderbilt University Medical Center (VUMC) and Friends 
in Global Health (FGH). We want to try a new way to offer HIV care and treatment to HIV 
positive couples who are expecting a child. Right now, couples can receive HIV testing together 
but can not enroll together in HIV treatment services. Pregnant women are enrolled in antenatal 
clinics (ANC) and men in adult HIV services.  
Couples who are in the intervention group of this study will be able to get HIV services with their 
partner. This will happen first in ANC and then in the Child at-Risk (CCR) clinic after delivery. 
Couples in the intervention group will also receive additional couples counseling and community 
based support from peer educators. We wantto see if couples who get these services together 
are better at staying on HIV treatment compared to couples in regular care.   
 
Procedures to be followed and approximate duration of the study 
This study will begin today and last for the next three years. If you and your partner agree to be 
part of this study, we will enroll you both into HIV care and treatment. All future clinical visits, 
counseling sessions, and drugs will be given to you at the ANC or CCR clinics. After you are 
enrolled in HIV treatment, you and your partner will be brought to meet with a couples’ 
counselor.  
We will also provide you both with a list of peer educators who successfully completed the steps 
of the prevention of mother-to-child treatment cascade. You will be able to choose the couple 
you wish to work with. Once you have made your choice, our study coordinator will arrange a 
meeting with you and your peer support couple in the next two weeks. Your peer supporters will 

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meet with you every month for the first seven months of your care. These meetings may be at 
your home or in another safe place you choose.  
We will access your medical records to see what medications you are taking, medical data 
about your health (CD4 cell count and viral load), and the dates you pick up your medications.  
A study staff person will also conduct two surveys at the beginning of your treatment and six 
months after you start treatment. You do not need to answer all the questions in the surveys if 
you do not want to. If a question makes you feel uncomfortable or you do not know the answer, 
it is ok to tell the interviewer that you do not want to answer the question. You can also stop the 
surveys at any time without any penalty. 
 
Expected Costs: 
None. 
 
Possible Risks  
The idea of providing HIV care and treatment together for couples expecting a baby is new and 
untested.  While we will provide extra counseling for this, there is a chance that you and your 
partner will not agree on ways to take medication or talk together. This could make more 
problems in your relationship.  If you feel any discomfort or have relationship problems please 
contact us as soon as possible so we can work to resolve it together.  
We know that talking about your personal experiences with HIV with your partner or health care 
workers can be uncomfortable. We will try to have a comfortable, honest, and relaxed 
discussion. Still we know that some of the questions we ask might make you feel uncomfortable. 
We will try to limit embarrassment as much as possible. No study staff will tell anyone else your 
responses to the survey questions.   
 
Possible Benefits  
The information you share may help us to offer better services for couples living with HIV who 
come for ANC services. This could benefit Mozambican society by improving health programs 
for people living with HIV. If the project is successful, you may have better communication and 
trust with your partner after our counseling sessions.  
 
What happens if you choose to withdraw from study participation?: 
Nothing. You are free to stop participating at any point without problem.  You only need to say 
that you would like to stop being in the study.  You can tell this to us at any time.   
 
Confidentiality 

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41 
 
We will make every effort to keep your personal information confidential. However, it’s not 
possible to guarantee total confidentiality. The clinical information obtained during this study will 
be kept with your medical record. These medical records are stored securely at the health 
facility.  
 
Privacy Information 
Your information may only be shared if you or someone else is in danger, or if we are required 
to do so by law. If this occurs, your information may be shared with VUMC, or the U.S. and/or 
Mozambican government. This includes, for example, the VUMC IRB, U.S. Federal Government 
Office for Human Research Protections, or the Mozambican Ministry of Health.   
 
Contact Information for Questions 
If you should have any questions about study or wish to have additional counseling related to 
your care, please feel free to contact the evaluation activities coordinator, Lazaro Calvo, at the 
FGH office in Quelimane at +258 24217100.   
 
For more information about giving consent or your rights, please feel free to contact the National 
Committee for Bioethics of Health in Mozambique at +258 824066350. You may also contact 
the VUMC Institutional Review Board (IRB) office in the U.S. at +001-615-322-2918. 
 
Do you have any questions? 
This form has been read and explained to me.  I have been given an opportunity to ask 
questions I have about the study. I understand that I may decide at any time that I do not want 
to continue participating in the study. I understand that I will receive a copy of this consent form. 
By saying yes, you agree to participate in Partner-based HIV care and treatment for the next 18 
months. You are agreeing to participate in our interviewer-administered surveys and that we can 
look at your medical records, and that of your unborn child. By saying no, you decline to 
participate in all parts of the study.  
Moderator: Answer the participant’s questions before proceeding to the next question. 
 
 
 
 
I give my consent to participate in the study. 
 
 
_________________________________              _______________ 

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42 
 
Printed Name of Patient 
 
         Date  
 
 
 
_________________________________              _______________ 
Signature of Patient  
 
         Date 
 
 
 
_________________________________              _______________ 
Signature of Witness (if thumbprint used) 
         Date 
 
 
 
_________________________________              _______________ 
Signature of Person Who Explained This Form      Date 
I have explained to the participant the study purpose and procedures and we have discussed all 
the risks that are involved.  I have answered questions to the best of my ability. 
 
 
 
 
 
Appendix 5: Informed Consent (control arm) 
 
This informed consent document applies to adults 18 years or older. This document is to 
be read aloud to the patients in the control arm. 
Age of patient: ____________ 
 
Introduction 
 
Thumbprint of Participant 

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43 
 
This consent form contains information about a new study to provide couples-based HIV care 
and treatment to pregnant couples. This form describes your rights as a participant. It is meant 
to answer your questions. We will read this form to you. Please feel free to ask any questions 
you may have about this.  
If you and your partner agree to participate in this program I will ask you to sign the form or 
make your thumbprint mark. Even if you agree to participate, you can stop participating at any 
time. I will give you a copy of this form. This form might contain some words that are unfamiliar 
to you. Please ask me to explain anything you do not understand. 
 
Purpose of this study  
This study is being done by staff from Vanderbilt University Medical Center (VUMC) and Friends 
in Global Health (FGH). We want to try a new way to offer HIV care and treatment to HIV 
positive couples who are expecting a child. Right now, couples can receive HIV testing together 
but can not enroll together in HIV treatment services. Pregnant women are enrolled in antenatal 
clinics (ANC) and men in adult HIV services.  
Couples who are in the intervention group of this study will be able to get HIV services with their 
partner. This will happen first in ANC and then in the Child at-Risk (CCR) clinic after delivery. 
Couples in the intervention group will also receive additional couples counseling and community 
based support from peer educators. Couples in the control group will complete two surveys, but 
otherwise will enroll in HIV care and treatment as they would normally. We want to see if 
couples who get these services together are better at staying on HIV treatment compared to 
couples in regular care.   
 
Procedures to be followed and approximate duration of the study 
This study will begin today and last for the next three years. If you and your partner agree to be 
part of this study, you will enroll into HIV care and treatment in ANC and Adult HIV care and 
treatment, respectively. After you are enrolled on HIV medication, you and your partner will be 
brought to meet with the study coordinator who will ask you and your partner to compete two 
surveys.  
A study staff person will also conduct the same two surveys at six months after you start 
treatment. If you give us permission, we can complete this survey at the health facility or at your 
home (depending on your preference). You do not need to answer all the questions in the 
surveys if you do not want to. If a question makes you feel uncomfortable or you do not know 
the answer, it is ok to tell the Interviewer that you do not want to answer the question. You can 
also stop the surveys at any time without any penalty. 
 
Expected Costs: 
None 
 

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44 
 
Possible Risks  
We know that talking about your personal experiences with HIV with your partner or health care 
workers can be uncomfortable. We will try to have a comfortable, honest, and relaxed 
discussion. Still we know that some of the questions we ask might make you feel uncomfortable. 
We will try to limit embarrassment as much as possible. No study staff will tell anyone else your 
responses to the survey questions.   
 
Possible Benefits  
The information you share may help us to offer better services for couples living with HIV who 
come for ANC services. This could benefit Mozambican society by improving health programs 
for people living with HIV. If the project is successful, you may have better communication and 
trust with your partner after our counseling sessions.  
 
What happens if you choose to withdraw from study participation?: 
Nothing. You are free to stop participating at any point without problem.  You only need to say 
that you would like to stop being in the study.  You can tell this to us at any time.   
 
Confidentiality 
We will make every effort to keep your personal information confidential. However, it is not 
possible to guarantee total confidentiality. The clinical information obtained during study will be 
kept in your medical record. These medical records are stored securely at the health facility.  
 
Privacy Information 
Your information may only be shared if you or someone else is in danger, or if we are required 
to do so by law. If this occurs, your information may be shared with VUMC, or the U.S. and/or 
Mozambican government. This includes, for example, the VUMC IRB, U.S. Federal Government 
Office for Human Research Protections, or the Mozambican Ministry of Health.   
 
Contact Information for Questions 
If you should have any questions about this study or wish to have additional counseling related 
to your care, please feel free to contact the evaluation activities coordinator, Lazaro Calvo, at 
the FGH office in Quelimane at +258 24217100.   
 
For more information about giving consent or your rights, please feel free to contact the National 
Committee for Bioethics of Health in Mozambique at +258 824066350. You may also contact 
the VUMC Institutional Review Board (IRB) office in the U.S. at +001-615-322-2918. 

Version 2 
 
45 
 
 
Do you have any questions? 
This form has been read and explained to you.  You have been given an opportunity to ask 
questions about the study. You know that you may decide at any time to not continue 
participating in the study. You understand that you will receive a copy of this consent form. By 
saying yes, you agree to participate in two surveys: one now and a second one in six months. 
You are agreeing that we can look at your medical records, and that of your unborn child. If you 
say no, you decline to participate in all parts of the study.  
 
Moderator: Answer the participant’s questions before proceeding to the next question. 
 
 
I give my consent to participate in the study. 
 
 
_________________________________              _______________ 
Printed Name of Patient 
 
         Date  
 
 
 
_________________________________              _______________ 
Signature of Patient  
 
         Date 
 
 
 
_________________________________              _______________ 
Signature of Witness (if thumbprint used) 
         Date 
 
 
 
_________________________________              _______________ 
Signature of Person Who Explained This Form      Date 
 
Thumbprint of Participant 

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I have explained to the participant the study purpose and procedures and we have discussed all 
the risks that are involved.  I have answered questions to the best of my ability.