Enhanced HIV/Sexually Transmitted Infections and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda
Phase: NA
Conditions: Pregnancy, Human Immunodeficiency Virus, Sexually Transmitted Diseases
Sponsor: Johns Hopkins University

 
  
  
ENHANCED HIV/STI AND PREGNANCY PREVENTION 
STUDY TO IMPROVE ADOLESCENT REPRODUCTIVE 
HEALTH SERVICES IN UGANDA 
  
(“Health Improvements-For-Teen Ugandans” or the HI-4-TU Study)  
                           
  
  
  
  
  
  
  
  
  
MAKERERE UNIVERSITY– JOHNS HOPKINS UNIVERSITY (MU-JHU)  
RESEARCH COLLABORATION  
(MUJHU CARE LTD)  
KAMPALA, UGANDA  
  
  
  
  
  
  
  
  
  
NCT02845284  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
PROTOCOL VERSION 3.0 
June 16, 2016 

Enhanced HIV/STI and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda. V 3.0 – 16  
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Protocol title: Enhanced HIV/STI and Pregnancy Prevention Study to Improve Adolescent                 
Reproductive Health Services in Uganda  
  
Short title: ‘HI-4-TU Study’ which stands for Health Improvements-For-Teen Ugandans   
  
Sponsor: Eunice Kennedy Shriver National Institute of Allergy and Infectious Diseases (NIAID), 
Grant # 5UM1 AI 069530    
  
Principal Investigator:   
Program Director/Co-Principal Investigator:  
Prof. Florence Mirembe M.MED, PhD  
Prof. Mary Glenn Fowler MD, MPH  
MU-JHU Care Ltd  
  
MU-JHU Care Ltd  
  
Upper Mulago Hill Road  
Upper Mulago Hill Road  
P.O. Box 23491, Kampala, Uganda  
P.O. Box 23491, Kampala, Uganda  
Tel:+ 256 414 541044  Fax: +256 414 543 002  
Tel:+ 256 414 541044  Fax: +256 414 543 002 E-
mail l : flomir2002@yahoo.com   
  
E-mail : mgfowler@mujhu.org  
  
Co-Investigator:  
  
Co-Investigator:  
Dr. Clemensia Nakabiito, MBChB, M.MED  
Dr. Philippa Musoke, MBChB, PhD  
MU-JHU Care Ltd  
  
MU-JHU Care Ltd  
  
Upper Mulago Hill Road  
Upper Mulago Hill Road  
P.O. Box 23491, Kampala, Uganda  
P.O. Box 23491, Kampala, Uganda  
Tel:+ 256 414 541044  Fax: +256 414 543 002  
Tel:+ 256 414 541044  Fax: +256 414 543 002  
E-mail: cnakabiito@mujhu.org                                      E-mail: pmusoke@mujhu.org  
 
Co-Investigator  
Dr. Monica Nolan MBBS, MPH  
MU-JHU Care Ltd  
  
Upper Mulago Hill Road  
P.O. Box 23491, Kampala, Uganda  
Tel:+ 256 414 541044  Fax: +256 414 543 002  
E-mail : mnolan@mujhu.org    
Project Coordinator  
Dr. Carolyne Akello MBChB, MSc  
MU-JHU Care Ltd  
  
Upper Mulago Hill Road  
P.O. Box 23491, Kampala, Uganda  
Tel:+ 256 414 541044  Fax: +256 414 543 002  
E-mail: cakello@mujhu.org  
 
Co-Investigator  
Dr. Samuel Kabwigu MBChB, M.MED  
MU-JHU Care Ltd  
  
Upper Mulago Hill Road  
P.O. Box 23491, Kampala, Uganda  
Tel:+ 256 414 541044  Fax: +256 414 543 002  
E-mail : skabwigu@mujhu.org  
 
Consultant/Adolescent Expert  
Mr. Peter Mpinga  
Naguru Teenage Information and Health Centre  
P. O. Box 27572, Kampala, Uganda  
Tel: +256-414-288304 Fax: +256-414-288305  
E-mail: mpinga_peter@yahoo.com  
Co-Investigator  
Ms. Juliane Etima, MA Counselling Psychology   
MU-JHU Care Ltd  
  
Upper Mulago Hill Road  
P.O. Box 23491, Kampala, Uganda  
Tel:+ 256 414 541044  Fax: +256 414 543 002  
E-mail: jetima@mujhu.org            
Social Scientist/Interviewer  
Ms. Nabukeera Josephine B. A ,M.A  Sociology   
MU-JHU Care Ltd  
  
Upper Mulago Hill Road  
P.O. Box 23491, Kampala, Uganda  
Tel:+ 256 414 541044  Fax: +256 414 543 002  
E-mail: josephinenabukeera@yahoo.co.uk  
                                              
Consultant/Statistician  
Fredrick Edward Makumbi, MS, PHD       
School of Public Health, College of Health Sciences  
Makerere University                
P. O. Box 7072, Kampala, Uganda       
Tel: +256-414-543872, Fax +256-414-531807      
E-mail: 
fmakumby@musph.ac.ug                       
Consultant/Obstetrician & Gynaecologist  
Prof. Josaphat Byamugisha, M.MED, PHD  
Head Dept of Obstetrics and Gynecology  
Makerere University                
P. O. Box 7072, Kampala, Uganda       

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Tel: +256-414-543872, Fax +256-414-531807    
E-mail: byamugisha2001@yahoo.com  
  
  
Table of Contents  
LIST OF ABBREVIATIONS AND ACRONYMS .......................................................................................... V  
PROTOCOL SUMMARY ............................................................................................................................ VI  
STUDY  SCHEMA .................................................................................................................................... VIII  
1  INTRODUCTION ...................................................................................................................................... 1 
1.1  BACKGROUND AND SIGNIFICANCE ........................................................................................................ 1 
1.2  STUDY HYPOTHESIS AND RATIONALE ................................................................................................... 6 
1.2.1  Study Hypotheses ........................................................................................................................ 6 
1.2.2  Rationale ..................................................................................................................................... 6 
1.3  INNOVATIVE ASPECTS OF THE PROPOSED STUDY .................................................................................. 7 
1.4  INSTITUTIONAL CAPACITY .................................................................................................................... 8 
2  RESEARCH AIMS AND OBJECTIVES ................................................................................................... 8 
3  DESIGN AND METHODS ...................................................................................................................... 10 
3.1 STUDY DESIGN .................................................................................................................................. 10 
3.2 STUDY SETTING AND POPULATION ...................................................................................................... 12 
3.2.1  Study Setting ............................................................................................................................. 12 
3.2.2  Study Populations ...................................................................................................................... 12 
3.3  QUALITATIVE COMPONENT ................................................................................................................ 13 
3.3.1  Focus Group Discussion (FGD) ................................................................................................. 13 
3.3.2  Key Informant Interviews (KII) .................................................................................................... 13 
3.3.3  In-depth Interviews (IDI) ............................................................................................................. 13 
3.4  THE RANDOMIZED CONTROLLED TRIAL COMPONENT .......................................................................... 13 
3.4.1  Recruitment ............................................................................................................................... 13 
3.4.2  Selection of the Study Population .............................................................................................. 13 
3.4.3  Study eligibility criteria ............................................................................................................... 14 
3.4.4  Informed consent processes ...................................................................................................... 14 
3.4.5  Randomization procedures ........................................................................................................ 14 
3.4.6 Intervention (Enhanced Peer Support Education and Counseling): ............................................. 15 
3.5 STUDY PROCEDURES......................................................................................................................... 16 
3.5.1  Follow-up and Study Exit Visits .................................................................................................. 18 
3.5.2  Behavioral Evaluations .............................................................................................................. 19 
3.5.3  Psychological Assessments ....................................................................................................... 19 
3.5.4  Clinical Evaluations and procedures .......................................................................................... 20 
3.5.5  Laboratory Evaluations .............................................................................................................. 20 
3.5.6 Retention .................................................................................................................................... 21 
3.6 STUDY ENDPOINTS ............................................................................................................................ 21 
3.6.1  Quantitative data outcomes ....................................................................................................... 21 
3.6.2  Qualitative data outcomes ......................................................................................................... 22 
3.7  STATISTICAL CONSIDERATIONS AND ANALYSIS PLAN ............................................................................ 22 
3.7.1  Sample size determination ......................................................................................................... 22 
3.7.2  Statistical analysis ..................................................................................................................... 22 
3.7.3  Qualitative data analysis ............................................................................................................ 23 

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3.8  DATA QUALITY AND MANAGEMENT ...................................................................................................... 24 
4  ANTICIPATED CHALLENGES AND MITIGATION PLANS ................................................................... 24 
4.1  MAINTAINING LONG –TERM COHESION AMONG PEERS ......................................................................... 24 
4.2  STIGMA AND DISCRIMINATION: ........................................................................................................... 24 
4.3  VULNERABILITY OF PREGNANT AND POSTPARTUM WOMEN TO RELOCATE: ............................................. 25 
4.4  MALE PARTNER AND FAMILY INVOLVEMENT: ........................................................................................ 25 
4.5 DEPRESSION AND PSYCHOLOGICAL DISTRESS: .................................................................................... 25 
5 HUMAN SUBJECTS PROTECTIONS .................................................................................................... 25 
5.1  INSTITUTIONAL REVIEW BOARDS/ETHICS COMMITTEES ....................................................................... 25 
5.2  RISK BENEFIT STATEMENT ................................................................................................................ 26 
5.2.1  Risks .......................................................................................................................................... 26 
5.2.2 Benefits ...................................................................................................................................... 26 
5.3 INFORMED CONSENT PROCESS .......................................................................................................... 26 
5.4  PARTICIPANT CONFIDENTIALITY ......................................................................................................... 27 
5.5  SPECIAL POPULATIONS ..................................................................................................................... 27 
5.5.1  Pregnant Women ....................................................................................................................... 27 
5.5.2  Children ..................................................................................................................................... 27 
5.6  COMPENSATION................................................................................................................................ 27 
5.7  ACCESS TO HIV-RELATED CARE (HIV COUNSELING AND TESTING AND HIV CARE)................................ 28 
5.8  STUDY DISCONTINUATION ................................................................................................................. 28 
6  PUBLICATIONS AND DISSEMINATION OF STUDY FINDINGS .......................................................... 28 
6.1  DISSEMINATION OF FINDINGS: ............................................................................................................ 28 
6.2  SUSTAINABILITY: ............................................................................................................................... 28 
7  TIMELINE .............................................................................................................................................. 29 
REFERENCES ........................................................................................................................................... 29 
APPENDIX A: ADDITIONAL BACKGROUND ON THE CONCEPT AND USE OF THE HEALTH BELIEF 
 ................................................................................................................................................................... 31 
MODEL ...................................................................................................................................................... 32 
APPENDIX B: SCHEDULE OF STUDY VISITS AND EVALUATIONS ...................................................... 33 
 
LIST OF ABBREVIATIONS AND ACRONYMS  
 
ACASI  
Audiovisual Computer Assisted Self Interview  
ALHIV  
Adolescents Living with HIV  
ANC    
Antenatal care  
ANOVA  
Analysis of Variance  
AP                Ante partum  
BP  
Blood Pressure  
CRF    
Case Record Form  
CRS     
Clinical Research Site  
CTU    
Clinical Trials Unit  
EBF     
Exclusive Breastfeeding  
FP    
Family Planning  
FGD  
Focus Group Discussion  
GCP  
Good Clinical Practices  
GPS  
Group Peer Support  
HEADDS  
Home & Environment, Education & Employment, Activity, Drugs, Sexuality,     
Suicide/Depression  
HBM    
Health Belief Model  
Hb  
  
Hemoglobin  
hCG    
Human Chorionic Gonadotropin  

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HI-4-TU  
Health Improvement for Teen Ugandans (Study)   
HIV  
Human Immunodeficiency Virus  
HSP    
Human Subjects Protection  
HTC  
HIV testing and counseling  
IDI  
In-depth Interview  
ICH  
International Conference on Harmonization  
IEC  
Information Education and Communication  
IMPAACT  
International Maternal Pediatric and Adolescent AIDS Clinical Trials Network  
IRB  
Institutional Review Board  
ITN  
Insecticide Treated Nets  
IPS    
Individual Peer Support  
JCRC  
Joint Clinical Research Centre  
JHU  
Johns Hopkins University  
KAP  
Knowledge, Attitudes and Practices  
KII  
Key Informant Interview  
MICH      
Maternal, Infant and Child Health  
MOH   
Ministry Of Health  
MTCT  
Mother-To-Child (HIV) Transmission  
MU-JHU  
Makerere University – Johns Hopkins University Research Collaboration  
NIH  
National Institute of Health  
PEPFAR  
Presidents Emergency Plan For AIDS Relief   
PNC    
Post Natal Care  
PP  
Postpartum  
PMTCT  
Prevention of Mother-To-Child (HIV) Transmission  
RCG  
Routine Care Group  
RH       
Reproductive Health  
RPR  
Rapid Plasma Reagent  
SES  
Socioeconomic status  
SIDI    
Serial In-depth Interview  
SOP  
Standard Operating Procedures  
STI  
Sexually Transmitted Infection  
STD  
Sexually Transmitted Disease  
T&C    
(HIV) Testing and Counseling    
TOT    
Trainer of Trainers  
TPHA    
Treponema Pallidum Hemagglutination Assay  
UNCST  
Uganda National Council for Science and Technology  
WHO   
World Health Organization  
            
                   
  
PROTOCOL SUMMARY   
  
Background   
Supporting pregnant adolescents and teen mothers to improve uptake of health services for themselves and 
their infants is a critical public health issue in Uganda. These health services include support during 
pregnancy and lactation to promote maternal and infant health and uptake of dual protection methods which 
both prevent HIV and other STIs and promote planning and spacing of subsequent pregnancies. Barriers to 
be overcome include negative and discriminatory attitudes among both health care providers and the 
adolescents’ own spouses or partners and families.[1-2] Most reproductive health (RH) and pregnancy 
services in public health settings are not adolescent friendly despite the adolescent population’s high risk for 
adverse pregnancy outcomes and HIV/STI incidence.   
  
Study Aims   

Enhanced HIV/STI and Pregnancy Prevention Study to Improve Adolescent Reproductive Health Services in Uganda. V 3.0 – 16  
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AIM 1: To assess health care provider and adolescent mothers’ Knowledge, Attitudes and Practices (KAP) 
regarding adolescent reproductive health and related health services and explore adolescents’ risk 
perception and motivation to utilize reproductive health services and use of dual protection methods.   
  
AIM 2: To compare the effectiveness of adolescent peer group support and education, one to one peer 
support and education and routine care to help pregnant adolescents aged 15 to 19 years to achieve effective 
family planning and reduce STI incidence through 6 to 9 months post-delivery. STIs to be evaluated will 
include HIV, Gonorrhea, Syphilis, Chlamydia, Bacterial Vaginosis and Trichomoniasis.  
  
Design: This study is a 3 arm randomized controlled trial with a qualitative formative component at baseline, 
and qualitative and quantitative assessments at specific follow-up visits.  
  
Study population: 519 adolescents who are pregnant attending antenatal care in Kampala and aged 15 to 
19 years at enrollment with no diagnosed pregnancy complications or serious co-morbidity.  
  
Duration: 12 months; the qualitative formative phase is planned to last 1 month and behavioral assessments 
to explore risk perception and motivation to utilize reproductive health services including uptake of dual 
protection will be conducted through the study duration. The randomized trial phase is planned to last about 
12 months with 3 months of enrolment and 9 months of post-partum follow-up.  
  
Interventions: Group Peer Support Education and Counseling (Arm 2) and Individual Peer Support and 
Education (Arm 3) as compared to routine care (Arm 1).   
  
Study sites: Antenatal and postnatal clinics at Mulago Hospital and MU-JHU Research Clinic.   
Noting Mulago Hospital is undergoing extensive renovation which may affect client volumes; one or more of  
KCCA Clinics including Kisenyi Health Center IV, Kawempe Health Centre IV, Komamboga Health Center 
III, Kawaala Health Center III and Kiswa Health Centre IV and/or China-Uganda Friendship Hospital 
Naguru and Nsambya Hospital would be added as recruitment sites if inadequate recruitment rates are 
achieved at Mulago Hospital alone.   
  
Study outcomes  
A. Quantitative data outcomes:   
Primary:   
i) 
Incidence of one or more STIs during study follow-up, with STIs confirmed by laboratory tests of HIV-1, 
Neisseria Gonorrhea, Treponema pallidum (Syphilis), Chlamydia trachomatis, Bacterial Vaginosis or 
Trichomonas vaginalis.   
ii) 
Reported (and validated) consistent condom use and uptake of effective contraceptive method 
Secondary:   
iii) Acceptability and desirability of assigned clinic service model  
  
B. Qualitative Data Outcomes:  
i) 
Teen mothers’ knowledge, attitudes and practice regarding teen reproductive health and related health 
services and risk perception and motivation to utilize reproductive health services and use of dual 
protection methods derived from FGD and single and serial IDIs  
ii) Health providers’ knowledge, attitudes and practice regarding provision of adolescent reproductive health 
services      
 

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STUDY  SCHEMA  
  
  
 
Screening  to identify   
Pregnant Adolescents aged 15 to 19 years   
at  ≥28  weeks gestation  
 
Mulago National Referral Hospital  
Kawempe Health Centre IV, Uganda - China  
Friendship Hospital  Naguru , Kiswa Health  
Centre  IV  and Nsambya  H ospital used if  
recruitment rate suboptimal at  Mulago  
Formative Research:   
FGDs with  consenting  
pregnant  and postpartum  
adolescents’ exploring KAP  
regarding reproductive health  
and pregnancy related  
services and perception of  
risk & dual protection  
Results to inform the design of  
interventions  
R andomized to one of 3 arms:   
N  = 519  
Control Arm /Arm 1 :  
Routine care as provided  
by the health care facility  
according to MICH  
schedule  
(N=215)  
 
 
Arm 2:  
Adolescent  Group  
Peer Support   
Intervention  
 (N=152)  
 
 
Arm  3 :  
Adolescent   
One - to - one  Peer  Support  
Intervention  
(N=152)  
 
Follow - up through 9 months postpartum or end of study whichever comes 1 st  as follows :  
Study visits each month after enrollment until delivery and at or near 6 and 10 weeks, 3, 6 and 9 months postpartum.  
HIV/STI and pregnancy tests conducted at enrollment,  3 , 6 and 9 months postpartum.  
 
1 2 FGDs done on  8 - 
randomly  
12 
pre selected participants at baseline and at study exit  
Serial IDIs done on 12 randomly  pr eselected participants at baseline, 1 0  weeks postpartum and at study exit  
Single IDIs done on those who se roconvert, ≥2 STI episodes and/or become pregnant again until saturation is reached and no  
new information is forthcoming from IDIs  
 Enrolment of consenting eligible  
adolescents    
Formative Research:   
KIIs with consenting health  
providers  exploring KAP  
regarding  adolescent  
reproductive health and  
provision of  services   

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1  INTRODUCTION   
1.1 Background and significance  
Supporting pregnant adolescents and teen mothers to improve uptake of health services for 
themselves and their infants is a critical public health issue in Uganda. These health services 
include support during pregnancy and lactation to promote maternal and infant health and 
uptake of dual protection methods which both prevent HIV and other STIs and promote 
planning and spacing of subsequent pregnancies. Barriers to be overcome include negative 
and discriminatory attitudes among health care providers and the adolescents’ own spouses 
or partners and families.[1-2] Most reproductive health (RH) and pregnancy services in public 
health settings are not at all adolescent friendly despite the adolescent population’s high risk 
for adverse pregnancy outcomes, HIV/STI incidence and subsequent sustained health, 
education and socioeconomic harms.    
  
Epidemiology of sexual and reproductive health among Ugandan teens     
  
Drawing from the 2011 and prior Demographic and Health Surveys, the 2011 AIDS Indicator 
Survey and other surveys and studies, some sobering statistics emerge which paint a picture 
of the lived experiences of many young women in Uganda.   
  
Uganda has one of the highest fertility rates in the world with a total fertility rate of 6.2 with a 
strong rural: urban (6.8:3.8) difference.[3-5] Teen motherhood is the norm with more than 1 in 
5 (21%) of 17 year old adolescents and more than half (58%) of 19 year old women pregnant 
or already having had one or more children[6]. Although there has been a continuing decline 
in early teen pregnancies rates which parallel a decrease in early teen marriage over the last 
20 years). Early marriage, household poverty, lack of education and rural residence are all 
associated with higher rates of teen pregnancy. Unmet family planning needs is highest in this 
age-group with 42% of mothers aged 19 or less reporting their babies were either wanted later 
or not at all.[5, 7]  
  
Teen pregnancies are not without risk for both mother and baby. Sadly Uganda has one of the 
highest global rates of maternal mortality with a stagnant Maternal Mortality Ratio of 438 (CI 
368-507). Around 1 in 6 female adolescent deaths (18%) among 15 to 19 year olds is a 
maternal death. 5% of mothers aged less than 20 reported receiving no antenatal care and 
two-thirds reported no postnatal check-up. Maternal age below 20 is also associated with a 
much higher rate of low birth weight and neonatal mortality (43/100 live births) than other 
maternal age groups under 40 years. Birth intervals less than the recommended 24 months is 
also highest (39%) among the 15-19 year old age group having their 2nd or subsequent 
pregnancy.      
  
Female sexual debut is at a median age of 17.5 (for the younger age cohort), and is below 
age 15 for ~12% of women and below age 18 for ~58% of women while the median age of 
marriage among younger women is slightly less than 18 years. The age of sexual debut has 
remained stable between the 2006 and 2011 Demographic and Health Surveys although the 
proportion of girls less than 15 years old when married has declined over time to 3% among 
the 15-19 year old age cohort. Being married is strongly associated with a younger age of 
sexual debut and teen pregnancy.   
  
About 1 in 3 (33%) never married adolescents aged 18 to 19 years report having had sexual 
intercourse in the last 12 months with just over half (52%) using a condom at their last sexual 
encounter. Among 15-17 year old never married girls about 1 in 6 (14%) reported being 

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sexually active in the previous 12 months with a similar proportion (55%) who reported condom 
use. Among all 18-19 year old young women reporting being sexually active, almost  
1 in 6 (16%) reported a partner at least 10 years older and almost 1 in 10 (9%) of 15 to 17 year 
olds reported a partner at least 10 years older. Being married had a very strong association 
with age-disparate relationships; with 19% of married women aged 15-19 reporting partners 
at least 10 years older versus 4% among unmarried women. In addition almost 1 in 6 (14%) 
of 15-19 year old married women reported co-wives as part of a polygynous marriage which 
was more prevalent in rural compared to urban areas.       
  
Sexual and/or physical violence is reported by 58% of 15 to 19 year olds including 19% 
reporting sexual violence. The current or former husband or partner was identified as the 
perpetrator of sexual violence by 65% of women aged 15-49 who had experienced sexual 
violence. However non-spousal sexual abuse was also prevalent with 6% of women reporting 
non-spousal sexual abuse by age 15 and 9% by age 18. Alcohol intoxication and 
intergenerational patterns (with women’s father having abused her own mother) were both 
associated with higher rates of violence of all forms whether emotion, physical and/or sexual.            
  
Uganda has a mature HIV epidemic with overall HIV seroprevalence among adolescent girls 
aged 15-19 estimated at 3.0% [6]. There is a steady rise by age category from 1.6%  among 
15-17 year old adolescent girls to 5.1% among 18-19 year olds and 7.1% for young women 
20 and 22 years old with a continued increase to an age-specific peak at 12.1% in  women 
aged 30 to 34 [6]. In contrast age specific male prevalence remains much lower reaching 4.0% 
in the 25-29 year old category before a rapid increase to 9.1% in the 30-34 year old age cohort. 
The survey data suggests that peak HIV incidence for women is in the late teens and early 
twenties whereas for men peak HIV incidence is a decade or so older [6]. More than 500 young 
women aged 15 to 24 years are estimated to be infected with HIV each week in Uganda; 
extramarital relationships remain a driver for HIV transmission to young women as well as 
within marital relationships[8]   
  
At the Mulago National Referral Hospital in Kampala Uganda there are over 43,000 pregnant 
women seen in the antenatal clinics (ANC) and almost 30,000 deliveries each year. Routine 
HIV testing with pre and post counseling is provided as part of PMTCT services and almost all 
women are tested. The figure below shows HIV testing by age for a 2 year period from July 
2012 through June 2014 from MUJHU PMTCT program data. The average HIV prevalence 
was 10.9% and 15 to 19 year olds represented 14% of the total women seen and tested. Of 
note HIV prevalence in the younger age groups largely equates to incidence of new sexually 
transmitted HIV infections (with the exception of the small perinatally infected population 
reaching reproductive age). It is perhaps self-evident that pregnant teens are expected to (and 
do) have a higher age-specific HIV prevalence rate than that found in the general teenage girl 
population as pregnant teens are both sexually active and have had unprotected sexual 
intercourse.           
  

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Courtesy MU-JHU PMTCT program data Nov 2014   
  
1 in 5 (19.7%) of teens aged 15 to 19 years self-report having had a sexually transmitted 
infection (STIs), genital sore, ulcer or discharge in the last 12 months. However sensitivity and 
specificity of these signs and symptoms among women is poor. Among men sensitivity and 
specificity is much higher and men aged 15 to 24 reported a prevalence of 14.3%. Among 
both women and men aged 15 to 49 slightly more than 1 in 4 (26 and 27% respectively) sought 
no treatment. A study carried out among adolescents in Kampala reported prevalence of 
20.6% of at least one STI.[10]  Access to diagnosis and treatment services for STIs as well as 
uptake and effective use of dual prevention methods to prevent STIs including HIV and 
effective contraception for prevention of unplanned pregnancies is an important public health 
issue among adolescents and youth. Adolescents who have already become pregnant are a 
particularly high risk group for repeat unplanned pregnancies and acquisition of STIs.[5]     
  
With financial support from CDC/PEPFAR, MUJHU implements comprehensive PMTCT 
services at Mulago Hospital including routine HIV screening for all pregnant mothers, partner 
testing; support to initiate and adhere to lifelong antiretroviral treatment (known as ‘Option B+’) 
and follow-up of mother-infant pairs and linkage to ongoing HIV, reproductive health and infant 
care services for those found to be HIV infected. However, current very crowded antenatal, 
labor and delivery and maternal and infant health services at Mulago Hospital are far from 
adolescent friendly despite the adolescent population’s increased risk for adverse pregnancy 
outcomes, repeat pregnancies and known relatively low health seeking behaviors.    
  
Peer education and support interventions: Evidence and behavioral theories     
  
Our intervention approach is primarily the provision and facilitation of education and support 
by peer educator/facilitators to their peers. Peer support is said to occur when people provide 
experience, emotional, social or practical help to each other.  Peer support is distinct from 
other forms of social support in that the source of support is a Peer.[11] The effectiveness of 
peer support is derived from a number of psychological processes which were described by 
Mark Salzer in 2002.[12] These processes include; social support, experiential knowledge, 
social learning theory, social comparison theory and the helpertherapy principle.[13]  
• 
Social support is the existence of positive psychosocial interactions with others with whom 
there is mutual trust and concern.[14] Positive relationships contribute to positive 
adjustment and buffer against stressors and adversities by offering (a) emotional 
 
4 % 
% 
2 
% 
4 
% 
5 
% 
6 
7 % 
% 
8 
% 
9 
% 
9 
10 % 
11 % 
11 % 
14 % 
0 % 
2 % 
4 % 
6 % 
8 % 
10 % 
12 % 
14 % 
16 % 
<=14 15 16 17 18 19 20 21 22 23 24 25 >= 
26 
Mulago Hospital PMTCT HIV prevalence by age 
Jul 12  - June 14, N = 87,871 (Average prev = 10.9%)  
<=14 
15 
16 
17 
18 
19 
20 
21 
22 
23 
24 
25 
>=  26 

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support[15] (esteem, attachment, and reassurance)[16] (b) instrumental support (material 
goods and services), (c) companionship [17] and (d) information support (advice, 
guidance, and feedback). [18]  
• 
Experiential knowledge is specialized information and perspectives that people obtain from 
living through a particular experience such as substance abuse, a physical disability, 
chronic physical or mental illness, or a traumatic event such as combat, a natural disaster, 
domestic violence or a violent crime, sexual abuse, or imprisonment. Experiential 
knowledge tends to be unique and pragmatic and when shared contributes to solving 
problems and improving quality of life. [19-20]  
• 
Social learning theory postulates that peers, because they have undergone and survived 
relevant experiences, are more credible role models for others. Interactions with peers who 
are successfully coping with their experiences or illness are more likely to result in positive 
behavior change [21]  
• 
Social comparison means that individuals are more comfortable interacting with others 
who share common characteristics with themselves, such as a psychiatric illness, in order 
to establish a sense of normalcy. By interacting with others who are perceived to be better 
than them, peers are given a sense of optimism and something to strive toward.[22]  
• 
The helper-therapy principle proposes that there are four significant benefits to those who 
provide peer support: [23-24] (a) increased sense of interpersonal competence as a result 
of making an impact on another person's life; (b) development of a sense of equality in 
giving and taking between himself or herself and others; (c) helper gains new personally-
relevant knowledge while helping; and (d) the helper receives social approval from the 
person they help, and others.[25]  
Peer education is a popular concept that implies an approach, a communication channel, a 
methodology, a philosophy, and a strategy. The English term ‘peer’ refers to “one that is of 
equal standing with another; one belonging to the same societal group especially based on 
age, grade or status”. The term ‘education’ (v. educate) refers to the “development”, “training”, 
or “persuasion” of a given person or thing, or the “knowledge” resulting from the educational 
process (Merriam Webster’s Dictionary, 1985). In practice, peer education has taken on a 
range of definitions and interpretations concerning who is a peer and what is education (e.g. 
advocacy, counseling, facilitating discussions, drama, lecturing, distributing materials, making 
referrals to services, providing support, etc.)[26]. Peer education typically involves the use of 
members of a given group to effect change among other members of the same group[27]. 
Peer education is often used to effect change at the individual level by attempting to modify a 
person’s knowledge, attitudes, beliefs, or behaviors. However, peer education may also effect 
change at the group or societal level by modifying norms and stimulating collective action that 
leads to changes in programmes and policies.[28]   
  
There are a number of behavioral theories which provide a coherent framework in support of 
peer education approaches to behavior change which include Social Learning Theory, the 
Theory of Reasoned Action, Diffusion of Innovation Theory and the Theory of 
Participatory Education. Numerous studies including those specifically in the field of HIV and 
reproductive health and targeting young women suggest that peer lead education and support 
coupled with professional services are superior to professional services alone [26] . The 
importance of peer group support among adolescents has been emphasized in a recent survey 
of adolescents living with HIV (‘ALHIV’); the adolescents indicated the positive impact of peer 
group based psychosocial support.  

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We also draw heavily on the Health Belief Model (HBM) in our conceptualization of the 
behaviors of interest (health service attendance and uptake of dual protection methods) and 
how to influence them in this study. The HBM is a psychological model that attempts to explain 
and predict health behaviors. This is done by focusing on the attitudes and beliefs of 
individuals. The HBM was first developed in the 1950s by social psychologists Hochbaum, 
Rosenstock and Kegels working in the U.S. Public Health Services. The model was developed 
to help explain the failure of a free tuberculosis (TB) health screening program. Since then, 
the HBM has been adapted to explore a variety of long- and short-term health behaviors, 
including sexual risk behaviors and the transmission of HIV/AIDS.   
  
Core Assumptions and Statements  
The HBM is based on the understanding that a person will take a health-related action (i.e., 
use condoms) if that person:   
1. Feels that a negative health condition (i.e., HIV) can be avoided,  
2. Has a positive expectation that by taking a recommended action, s/he will avoid a negative 
health condition (i.e., using condoms will be effective at preventing HIV), and  
3. Believes that s/he can successfully take a recommended health action (i.e., s/he can use 
condoms comfortably and with confidence   
  
The HBM was spelled out in terms of four constructs representing the perceived threat and 
net benefits: perceived susceptibility, perceived severity, perceived benefits, and perceived 
barriers. These concepts were proposed as accounting for people's "readiness to act." An 
added concept, cues to action, would activate that readiness and stimulate overt behavior. A 
recent addition to the HBM is the concept of self-efficacy, or one's confidence in the ability to 
successfully perform an action. This concept was added by Rosenstock and others in 1988 to 
help the HBM better fit the challenges of changing habitual unhealthy behaviors, such as being 
sedentary, smoking, or overeating.   
  
In the intervention arms, the peer educators will be explicitly trained to use the Health Belief 
Model and assist their peers to explore perceived susceptibility, perceived severity, perceived 
benefits, perceived barriers and self-efficacy with the aim of adopting healthier behaviors.  
  
These peer mothers will offer individualized support and education to their assigned 
adolescents during study visits scheduled together with their routine clinic visits. The design 
of the individualized peer intervention arm builds on prior pilot work by MUJHU researchers in 
the Mulago PMTCT program. In 2012 the team completed an implementation science study 
providing individual peer support by “Family Planning (FP) Champions” to support uptake of 
family planning among newly delivered mothers. This pilot FP intervention showed increased 
uptake of FP services from 33% prior to the peer FP intervention to 61% among women during 
the intervention and 45% post intervention[29]. This preliminary work provides support for 
testing the one-to-one peer intervention in a randomized implementation study.    
  
The peer educators selected will be young mothers who have successfully taken up 
contraception or dual methods (including consistent condom use) postpartum themselves who 
can thus serve as both peers and positive role models.   
  
  
  
Study design, study population and setting     
  

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The MUJHU Clinical Research Site (CRS) under the Johns Hopkins University Clinical Trial 
Unit (JHU CTU) research scope includes primary prevention of HIV and reproductive health.  
This NIH sponsored HI-4-TU MUJHU Study is an adolescent focused implementation science 
study directed at improved social support and dual prevention of both HIV/STI’s and 
subsequent unplanned pregnancies.   
The intended study population is 519 currently pregnant adolescents (without diagnosed 
pregnancy related complications or serious co-morbidity) who are attending antenatal care in 
Kampala and are aged 15 to 19 years at enrollment with follow-up through 6 to 9 months after 
delivery.    
We will use a randomized study design to test the acceptability and effectiveness of two 
enhanced peer lead, reproductive health promotion interventions compared to routine health 
care. The study participants will be individually randomized to one of three arms.   
• 
Routine Care (Arm 1): Group education and counseling from ANC clinic midwives, routine 
PMTCT services including routine HIV C&T and family planning and partner C&T services 
for those requesting it.   
• 
Intervention Arm Two: Routine Care plus group peer education and support beginning 
every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post-
delivery.   
• 
Intervention Arm Three: Routine Care plus individual peer education and counseling 
beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3,6 and 9 
months post-delivery.   
  
1.2 Study hypothesis and Rationale   
1.2.1 Study Hypotheses  
We hypothesize that there will be a significantly lower incidence of HIV/STIs and increased 
uptake of dual protection and effective family planning methods in the intervention groups 
compared to the group receiving routine care i.e. we hypothesize intervention arms will be 
superior to routine care for our primary outcomes.   
  
We further hypothesize that the group peer support intervention will be superior to the 
individual peer support arm in achieving a secondary outcome of improved self-esteem and 
self-efficacy (possibly mediated through improved social connectedness and a reduced sense 
of isolation and internalized stigma) however our study is not powered to detect the small 
differences we would hypothesize in our primary outcomes of STI incidence and uptake of 
dual protection methods between intervention arms.                  
1.2.2 Rationale  
Adolescent pregnancy often curtails a woman’s opportunity for further education, employment 
and economic independence and is associated with a higher risk for pregnancy related 
complications including maternal and infant mortality, gender based violence, subsequent 
narrowly spaced pregnancies and HIV and other STI infection. The rates of pregnancy, 
maternal mortality, HIV incidence and gender based violence among adolescent girls in 
Uganda are among the world’s highest and represent an unconscionable disease burden and 
violation of human rights[30]    
  
In most resource-limited settings including Uganda, routine antenatal and postnatal services 
are not adolescent friendly and often present additional barriers for adolescents to access 
comprehensive health care including dual prevention methods, especially for unmarried 

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‘minors’. Uganda National Guidelines for Research involving Humans as Research 
Participants (version July 2014)[31] defines “emancipated minors as individuals below the age 
of majority who are pregnant, married, have a child or cater for their own livelihood.” 
Emancipated minors should be able to access health services primarily for their own health 
without the consent of parents or partners however practice and policy remain far apart.     
  
These data highlight the need for innovative yet realistic and cost-effective interventions to 
promote adolescent reproductive health including among the especially vulnerable group of 
pregnant adolescents.   
  
There is moderate strength data which suggests well run peer education and support services 
might provide just such practical and cost-effective intervention models however there are few 
randomized controlled trials to date with none among pregnant teens and none that compare 
individual to group peer education and support to our knowledge.[28]   Given the need to 
allocate scarce resources to evidence-based interventions which achieve maximum cost-
effectiveness we argue that the results of our study may have important policy implications for 
a highly vulnerable population suffering a disproportionate disease burden.              
1.3 Innovative aspects of the proposed study   
Innovative aspects of this study include:   
Study design in that individually randomized controlled trials have not been conducted 
previously to evaluate peer interventions in this key neglected population nor to compare 
individual versus group peer interventions in an adolescent friendly clinic.     
Peer lead model drawing on young mothers who are both peers and role models  
• 
Use of currently available information & communication technology in Uganda to send 
study visit reminders and maintain contact with participants through sms or phone 
calls.   
• 
Collection of cost data to inform planning of replication and scale-up if successful   
• 
Capacity building among young peer leaders as a secondary study benefit       
This project will test two, innovative, peer-lead, adolescent friendly, reproductive health 
interventions specifically tailored to pregnant and postnatal adolescent mothers which is a key 
neglected population suffering a high disease burden. In this study we seek to use peer lead 
interventions coupled with credible professional advice to educate, support and empower 
adolescent mothers to consider and achieve their reproductive goals (our study end points), 
which is conceptualized as critical to achieve their broader life goals (ultimate impact).   
  
The peer education and support in both intervention arms will be provided by young peer 
mothers who have successfully dealt with a number of issues that the expectant adolescents 
and young mothers are dealing with in their lives including uptake of contraception (or dual 
prevention methods) after delivery. They are selected to be both a credible peer and a positive 
role model to the study participants. The peer mothers will receive training in the use of an 
adolescent tailored reproductive health curriculum that is interactive and that includes role 
playing to help sexually active adolescents identify and reduce sexual risks including 
negotiation of condom use. This will draw from the Comprehensive Family Planning and 
Reproductive Health Training Curriculum for adolescents.[32] In addition available Uganda 
MOH and other already developed IEC materials will be used and adapted.   
  
The planned intervention study will also collect relevant human and other resource and cost 
data to inform subsequent replication and scale-up.  
  

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Capacity building is also anticipated as a secondary benefit with training and mentoring of 
young peer educators/leaders as well as training and mentoring of health service care 
providers in the provision of dual protection methods, adolescent friendly health service 
practices including screening and treatment of STIs and promotion of reproductive and sexual 
health tailored to adolescents.  
1.4 Institutional Capacity  
  
MUJHU celebrated its 25th anniversary in 2013 as a leading research institution focused on 
maternal and children’s health in Uganda. MUJHU is a long standing collaboration between 
Makerere University and Johns Hopkins University and became a Ugandan not for profit 
registered company in 2006. MUJHU continues to participate in NIH sponsored clinical trial 
research networks focused on PMTCT, maternal and pediatric health and primary prevention 
(currently IMPAACT and MTN networks) and has conducted multiple perinatal HIV prevention 
clinical trials including the landmark HIVNET012, SWEN and HPTN046 studies. In addition 
MUJHU has successfully applied for clinical research, implementation science and 
programmatic implementation grants from a number of diverse sources (US, European, 
Canadian and other) both directly as a prime and in consortia with other partners (including 
University of California in San Francisco, Emory University, Harvard University and MJAP).         
   
In the various clinical trials MUJHU has achieved very high retention rates due to the close 
monitoring of study participants using peers and health visitors, who counsel and advise, 
remind them about study visits, and visit them at home when necessary. MUJHU also works 
closely with the MUJHU Core Laboratory which is one of the few CLIA certified laboratories in 
SubSaharan Africa.   
  
Through its founder Professor Mmiro (now deceased and former Chair of the Department of 
Obstetrics and Gynaecology), Dr Nakabiito (Study Co-Investigator) and Professor Mirembe 
(Study PI) and its many research studies and support to PMTCT program services MUJHU 
has a very deep and long standing relationship with Makerere University’s Ob/Gyn Department 
and Mulago Hospital’s reproductive health services. MUJHU has assisted Mulago to 
implement its PMTCT program since 2000 when the 1st efficacious simple ARV interventions 
for PMTCT were described. Since 2002, peer mothers have been a central element of this 
program providing testimony, education, support and hope to their peers in individual, couple, 
group and community settings.        
  
Up to 2012 MUJHU also implemented a family model of comprehensive HIV care including 
care to all family members of HIV-positive female clients including adolescents many of whom 
were perinatally infected. MUJHU also hosts a vibrant mentored peer support program for 
children, adolescents and youth called ‘Young Generation Alive’ which from its beginning in 
2005 with 5 members now boasts more than 300 members including charismatic inspiring 
peer leaders and success in reducing school dropouts, teen pregnancies and improved self-
esteem. It is from among this group that some of the peer educators are expected to be 
recruited. MUJHU also successfully implemented a peer Senga study exploring partnership of 
HIV mothers(peers), community women and men (sengas/kojas) and village health teams to 
improve postpartum follow up in PMTCT[29]  
  
  
  
   
2 RESEARCH AIMS AND OBJECTIVES  
   

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AIM 1: To assess health care provider and adolescent mothers’ Knowledge, Attitudes and 
Practices (KAP) regarding adolescent reproductive health and related health services and 
explore adolescents’ risk perception and motivation to utilize reproductive health services 
and use of dual protection methods.   
  
Objective 1.1: To describe health workers knowledge, attitudes and practices about the 
provision of adolescent reproductive health services as well as their perceptions of 
barriers to adolescent uptake of services and health promoting behaviors.     
  
Objective 1.2: To describe adolescent knowledge, attitudes and practices in relation to 
their own reproductive health and uptake of health services and explore adolescents’ 
sexual risk perception and motivation and use of dual protection methods.     
  
AIM 2: To compare the effectiveness of adolescent peer group support and education, one to 
one peer support and education and routine care to help pregnant adolescents aged 15 to 19 
years to achieve effective family planning and reduce STI incidence through 6 to 9 months 
post-delivery. STIs to be evaluated will include HIV, Gonorrhea, Syphilis, Chlamydia, Bacterial 
Vaginosis and Trichomoniasis.  
  
Note: Routine care currently includes PMTCT services with HIV C&T and Uganda Ministry of 
Health messages given by midwives about healthy pregnancies during antenatal visits, and 
reproductive health at the 6 week postnatal visit; with referral for family planning for interested 
women.  
  
Objective 2.1: To describe and compare baseline demographic and clinical 
characteristics of the study participants at enrollment by arm.   
  
Objective 2.2: To describe and compare incidence of one or more STIs (including HIV) 
during study follow-up by study arm.   
  
Objective 2.3: To describe and compare uptake of dual prevention methods 
(contraceptive services and condom use) during study follow-up by study arm  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

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3 DESIGN AND METHODS    
3.1 Study Design  
Formative Research  
We will first conduct formative research with adolescents similar to the study participants to 
assess knowledge, attitudes and practices related to adolescent reproductive health and 
services. About two FGDs shall be conducted on consenting pregnant and postpartum 
adolescents aged 15 to 19 years, ensuring all ages are represented. Key informant interviews 
will be done prior to the study enrolment with targeted, experienced, reproductive health care 
providers to better understand their perceptions of reproductive health service needs and gaps 
among pregnant and postpartum adolescents. These data will together inform further 
refinement of the peer support and education interventions.      
We shall also collect qualitative data soon after enrollment during pregnancy, at about 10 
weeks postpartum and at study exit using serial in-depth interviews with about 12 randomly 
selected adolescent mothers as well as about two FGDs soon after enrollment and at study 
exit. In addition single IDIs will be conducted with participants who become HIV-infected, have 
>2 STIs or a repeat pregnancy during study follow-up until saturation is reached and no further 
new information appears forthcoming. These qualitative data will be triangulated to describe 
adolescents’ knowledge, attitude, practices and risk perceptions related to their own sexual 
and reproductive health (RH) and related health services and to ascertain the extent to which 
they perceive the available RH services as teen friendly or not in terms of acceptability and 
accessibility.   
Randomized Controlled Trial  
We will conduct a 3-arm, randomized, controlled trial of 519 pregnant adolescents aged 15 
through 19 years at enrollment to test the acceptability and effectiveness of two enhanced 
adolescent friendly reproductive health prevention interventions versus current routine care.  
In each intervention group, 152 adolescent mothers will be randomized to either the enhanced 
group peer support education and counseling intervention or to the enhanced one-to–one 
(individual) peer support education and counseling group with a young, model, peer educator 
trained to deliver RH education and counseling messages, beginning during pregnancy (≥ 28 
weeks) and followed up to 9 months postpartum or study end at or after 6 months (whichever 
comes first). The control group will consist of 215 adolescent mothers randomized to routine 
care as provided at Mulago hospital (or the designated health facility) where midwives deliver 
group sessions during antenatal and postpartum care visits as well as standard PMTCT 
services including routine opt-out HIV C&T and availability of partner C&T. Syphilis testing 
should also be routinely provided and treatment provided for infected pregnant mothers and 
their partners as per local standard of care.  
The 3 groups will be enrolled with study visits at 3, 6 and 9 months post-partum however the 
intervention groups (Arms 2 and 3) will have additional visits at 36 weeks Antepartum, delivery, 
6 and 10 weeks postpartum, Quantitative baseline data will be collected on routine 
demographic characteristics, reproductive history, pregnancy intentions and sexual 
risk/perceptions and HIV/STI status.  
  
  
  
Summarized table 1 of the study schedule and evaluation  
  

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SCR/ 
ENR  
36 
weeks 
APT  
Birth†  
  
6 weeks  
PPT  
  
10 
weeks 
PPT  
3 months 
PPT  
6 months 
PPT  
9 
months 
PPT†  
Arm 1– Routine Care  
X  
  
  
  
  
X  
  
X  
Intervention: 
Enhanced 
Counseling 
Education Sessions/Routine care as 
provided  
X  
  
  
X  
X  
X  
X  
X  
Behavioral  Assessments using IAQ and 
ACASI  
X  
  
  
  
X  
  
X  
X  
Psychosocial Assessment  
X  
  
  
  
  
X  
  
X  
Obtain/review and update RH and  
Medical History   
X  
X  
*  
*  
*  
*  
*  
X  
Clinical Examination – Blood Pressure, 
Weight, Obstetric exam  
X  
X  
  
  
  
  
  
  
Prescribe contraceptives  
  
  
  
X  
*  
*  
*  
*  
Provide available test results  
X  
X  
  
*  
*  
X  
*  
X  
Provide  
treatment/referral 
 
as appropriate  
*  
*  
*  
*  
*  
*  
*  
*  
LABORATORY  
 
  
Blood  
HIV-1    Serology  
(rapid 
tests)  
X  
  
  
  
  
X  
  
X  
Syphilis  
serology  
RPR 
(TPAB if positive)  
X  
  
  
  
  
€  
  
X  
Urine  
Protein and Glucose  
X  
X  
  
  
  
  
  
  
Rapid test for Gonorrhea  
infection  
X  
*  
  
*  
*  
*  
*  
X  
Rapid test for Chlamydia  
infection  
X  
*  
  
*  
*  
*  
*  
X  
HCG test  
  
  
  
*  
*  
*  
*  
X  
Pelvic  
Rapid  
test  
for 
Trichomoniasis   
X  
*  
  
*  
*  
*  
*  
X  
Collect  Vaginal  swab  
for 
Bacterial Vaginosis testing  
x  
*  
  
*  
*  
*  
*  
X  
Collect vaginal swab for 
testing 
presence 
of 
Y 
chromosome ‡  
  
  
  
  
  
  
  
X  
QUALITATIVE COMPONENT  
 
Serial In-depth Interview (SIDI)  
X  
  
  
  
X  
  
  
X  
Focus Group Discussion (FGD)  
X  
  
  
  
  
  
  
X  
Single In-depth Interview (IDI)  
  
  
  
*  
*  
*  
*  
*  
X mandatory, *If indicated, †contact at birth only for the intervention groups, € repeat at 6months if 
positive at enrolment, ‡ done only at study exit for participants with self-reported consistent condom 
use,   
† month 9 will be the study exit visit for most participants however month 6 may the exit visit for the last 
participants to enroll hence additional exit evaluations would be done then    
  
  

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3.2 Study Setting and population  
3.2.1 Study Setting  
The study will enroll participants from Mulago National Referral hospital antenatal clinics in 
Kampala. If recruitment at Mulago hospital is insufficient (due to the current ongoing hospital 
rehabilitation works), we will recruit patients from the Uganda China Friendship hospital, 
Naguru in Kampala, KCCA Clinics including Kisenyi Health Center IV, Komamboga health 
center III, Kawaala Health center III and Kiswa Health Centre III and/or Nsambya hospital.  All 
these hospitals have established PMTCT programs and see a substantial number of pregnant 
adolescents in their antenatal care clinics and they provide PTCT services and group 
education sessions in the ANC and PNC Clinics on maternal and child health as part of routine 
care.  
  
In order to prevent cross-contamination between the control and intervention arm populations, 
the group education and counseling sessions will take place at the MU-JHU Research 
premises. All other routine and individual peer support and education services will take place 
on site at the health care facility providing ANC and PNC services.    
3.2.2 Study Populations  
 
3.2.2.1  
 Study populations for formative phase:   
Randomly selected pregnant and postpartum adolescent girls similar to the study population 
will have 2 FGDs conducted; each FGD will involve 8-10 participants.   
KIIs will be conducted with 8 experienced health providers providing RH services at Mulago 
Hospital and the other targeted health facilities.   
  
 
3.2.2.2  
Study population for the randomized controlled trial component:   
519 pregnant adolescents’ ages 15-19 years recruited from the Mulago Hospital* ANC Clinic 
who are interested in participating in this study; agree to follow up and provide written informed 
consent with no diagnosed comorbidities including significant pregnancy related 
complications.    
Selection of participants will be by systematic sampling to ensure that the study population is 
evenly sampled.  
* KCCA Clinics including Kisenyi Health Center IV, Kawempe Health Centre IV, Komamboga Health 
center III, Kawaala Health centerIII and Kiswa Health center IV, Uganda-China Friendship 
hospital Naguru and Nsambya hospitals will be used if accrual of recruitment from Mulago 
hospital is not sufficient  
  
3.2.2.3     Study population for the qualitative component:   
Randomly selected pregnant adolescents will have 12 FGDs (8 – 12) participants in each 
group) at baseline and at study exit visit.   
  
We will also have serial IDIs (SIDI) with other randomly selected pregnant adolescents at 
baseline, 10 weeks and at study exit. A total of 12 participants will be interviewed, 4 in each 
study arm.   
Selection of participants will be by maximum variation sampling to ensure that all age groups 
are well represented.  
  

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Single IDIs will be conducted with participants who seroconvert, become pregnant (second 
pregnancy), or those who acquire 2 or more episodes of STIs during the study duration until 
saturation is reached with no new information forthcoming.   
3.3 Qualitative Component    
3.3.1 Focus Group Discussion (FGD)  
FGDs will be conducted for each of the study arms at baseline and at study exit (6 to 9 months 
postpartum). The participants will be categorized according to age groups for each of the arms; 
15-17 years and 18-19 years with each of the groups having FGDs at baseline and study exit.  
The total number of FGDs will be 12, and the target number per group will be 8-12 participants 
(n=8-12). A focus group interview guide will be used to obtain information from the FGDs and 
the sessions will be audio recorded and transcribed. Themes for FGD guide will be developed 
and will have the same themes for both pregnant adolescents and adolescent mothers but 
probes will be modified to suit targeted periods.  
3.3.2 Key Informant Interviews (KII)    
KIIs will be conducted with 8 experienced RH providers at the Mulago hospital and other 
targeted health facilities. An interview guide will be used that will elicit information on key 
informants knowledge, attitudes and practices towards provision of RH services to 
adolescents and perceptions of the barriers to uptake of RH services and healthier sexual and 
RH  related behaviors among adolescent girls.    
3.3.3 In-depth Interviews (IDI)   
Serial IDIs (SIDI) with 12 randomly preselected pregnant adolescents (4 each arm) will be 
conducted at baseline, 10 weeks and at study exit. Participant’s attitudes, beliefs and practices 
towards pregnancy and RH services will be collected using behavioral CRFs at baseline, 10 
weeks and study exit to assess any changes over time. In addition, participants HIV/STI risk 
perception and motivation to utilize RH services including condom use will also be assessed.  
Single In-depth Interviews will also be conducted for participants who seroconvert, become 
pregnant, or those who acquire 2 or more episodes of STIs during the study duration.  Serial 
In-depth Interviews will be conducted for randomly pre-selected participants at baseline, 10 
weeks and about 2 weeks post study exit.  In the event that a participant selected for a serial 
IDI either seroconverts, becomes pregnant, or acquires 2 or more episodes of STIs, then the 
last IDI will be conducted at the point when the end point occurs.   
3.4 The Randomized Controlled Trial Component   
3.4.1 Recruitment  
Recruitment of the adolescent mothers aged 15 to 19 years will be done from the Antenatal 
clinic (ANC) at Mulago Hospital. If the recruitment rate is below predetermined levels then 
recruitment will be expanded to one or more of KCCA Clinics including Kawempe Health 
Centre IV, Komamboga Health Center III, Kawaala Health center III and Kiswa Health Centre 
IV, Uganda-China Friendship Hospital Naguru, and Nsambya Hospital. The expectant 
adolescent mothers will be ≥28 weeks of gestation as ascertained by their medical records. 
Potential participants will be informed about the study and those interested will be supported 
through the informed consent process.  
3.4.2 Selection of the Study Population  
The inclusion and exclusion criteria in Sections 3.4.3.1 and 3.4.3.2 are used to ensure the 
appropriate selection of study participants.  

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3.4.3 Study eligibility criteria   
 
3.4.3.1  
Inclusion criteria  
At the time of screening participants must meet all of the following criteria to be eligible for 
inclusion in the study:  
I. 
Aged 15 through 19 years (inclusive)   
II. 
Pregnant at ≥28 weeks of gestation as documented in her medical records  
III. 
Able and willing to provide written informed consent to be screened for and take part 
in the study  
IV. 
Able and willing to provide adequate locator information with residence within 30 km 
radius from the MUJHU study clinic and to receive a home visitor visit   
V. 
Able and willing to come for follow up visits and to receive study follow up phone calls  
 
3.4.3.2  
Exclusion criteria  
Participants who meet the following criterion will be excluded from the study:  
I. 
Serious illness or social conditions that would prevent adherence to study 
requirements  
II. 
High risk pregnancy or fetal death in utero (with the exception of risk defined only by 
maternal age)   
Of note, HIV infection is NOT an exclusion criterion.   
3.4.4 Informed consent processes  
Written informed consent will be obtained from all potential participants for the formative 
research including adolescents participating in the FGDs and health professionals 
participating in the KIIs. The Informed Consent Forms (ICF), in English and Luganda will 
provide information about the FGD and any possible risks and benefits associated with 
participation.  As the KII is with health providers, the KII ICF will be in English.    
  
Written informed consent will be obtained from all potential study participants prior to enrolling 
in the randomized clinical trial. The Informed Consent Form (ICF), in English and Luganda will 
provide detailed information on what the study is about, the study procedures, and any 
possible risks and benefits associated with study participation in accordance with Good 
Clinical Practice Guidelines.    
3.4.5 Randomization procedures   
Prior to the study commencing, a randomization list will be prepared by the Data Manager at 
MU-JHU. This list will be computer-generated using random-sized block groups and will 
include consecutive intervention numbers with corresponding random intervention 
assignments. The randomization list will be encrypted in a password-protected file and backed 
up on the MU-JHU server. Encrypted copies of the original randomization list and 
documentation of the procedure used to generate the lists will be stored in the project 
administrative computers in MU-JHU and backed up on the MUJHU server. At enrolment, the 
MU-JHU Data Center will issue randomization numbers to the study coordinator based on the 
participants’ group allocation. These random numbers will be placed in envelopes and placed 
at a centralized location where study counselors may access them. After signing the informed 
consent and the participant is deemed eligible (based on the study eligibility criteria listed 
above), the participant will then open the sealed envelope and reveal the study group they are 
randomly assigned to. Assignment of randomization is considered the effective act of 
participant enrolment.  

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3.4.6 Intervention (Enhanced Peer Support Education and Counseling):   
Routine care is the care currently provided at the hospitals/ health centers during pregnancy, 
delivery and postpartum.   
Per the Uganda clinical guidelines 2012 [33], the main objectives of antenatal care are: 
prevention and treatment of any complications, emergency preparedness, birth planning, 
satisfying any unmet nutritional, social, emotional, and physical needs of the pregnant woman, 
provision of patient education, including successful care and nutrition of the newborn, 
Identification of high-risk pregnancy and encouragement of (male) partner involvement in 
antenatal care.  
  
For normal uncomplicated pregnancies, pregnant mothers are usually scheduled to have 4 
routine visits during pregnancy; at 10–20 weeks, 20–28 weeks, 28–36 weeks and >36 weeks. 
At all these visits, risk assessment, fetal growth monitoring, health education and plans for 
delivery are made by nurses/midwives with referral to clinicians/obstetricians (where clinically 
indicated and available). Risk assessment is done by history taking, examination including 
blood pressure and weight measurement and investigations (recommended routine laboratory 
investigations include RCT, RPR for syphilis, Hb, urine for albumin and glucose). Other tests 
are recommended as appropriate for the individual patient to assess maternal well-being, e.g. 
ultrasound, amniotic fluid, fetal heart/movements)  
  
Health promotion/education is usually delivered in group sessions by the nurses/midwives and 
issues discussed include;  involvement of husbands in ANC, delivery plans, discuss future FP, 
discuss symptoms of miscarriage, pregnancy-induced hypertension (PIH), education and 
counseling on PMTCT of HIV and malaria prevention and use of insecticidetreated bed-net 
(ITN), education on danger signs  in pregnancy, proper nutrition, adequate hygiene, 
breastfeeding and breast care, sexual activity during pregnancy, dual protection for FP/HIV, 
avoidance of smoking and alcohol and any problems are addressed.  
  
Postpartum, the mother is counseled on contraception and appropriate method provided if 
required, mother is advised to abstain from sexual activity for at least 6 weeks after birth, 
mother is asked if both her and baby are sleeping under ITN (encouraged if not), new born 
hygiene and baby care, she is also advised on when to seek care as follows: scheduled infant 
immunizations 6 and 10 weeks, 3, 6, 9 and 12 months postpartum and at other times should 
the baby fall sick.   
  
Routine care in ANC/PNC clinics varies within hospitals/health centers depending on available 
resources and also among healthcare providers; hence the standard of care described above 
is not what is provided. The basic minimum that is usually provided is obstetric care, delivery 
plans and health education which is not standardized and there may be stock-outs of essential 
laboratory commodities and pharmacy hours are restricted. In practice even at the national 
referral hospital it is not uncommon for pregnant women not to receive Hemoglobin, syphilis 
or urine screening tests (as confirmed by triangulated data from women’s self-reports in AIS 
2011. [6]    
  
The routine care group (control Arm 1) will have their visits conducted in the ANC/PNC clinic 
following the usual care as provided in these clinics, as summarized above.  
The intervention groups will also have the routine care as provided within Mulago hospital or 
the designated health facility and in addition will have the enhanced interventions which will 
focus on providing support and education including reproductive health information to the 
pregnant and postnatal adolescents on their risk of HIV/STI acquisition, and condom use 
utilizing adolescent friendly IEC materials and interactive exchanges either in a group or one-

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to-one. They will also receive counseling on the importance of family planning and those 
interested will be referred to the family planning clinic for provision of their choice of the 
effective available family planning methods. In addition, the interventions will also provide 
education on the importance of delivery in a hospital, post-natal care, infant feeding and 
importance of immunization for the baby. Both enhanced intervention groups will receive pre 
appointment reminders of follow up appointments through sms or phone calls if they agree. 
The adolescent group education counseling sessions will be done by trained, experienced 
peer educators during around 6 sessions conducted in the MU-JHU clinic. The one-to-one 
peer support and education counseling sessions will occur in the ANC for pregnant 
adolescents (in different clinic space from the routine care group) and postpartum the sessions 
will be held in the adolescent clinic (ward 15) in Mulago Hospital. The enhanced intervention 
sessions will occur in different places from each other and from the control group so as to 
minimize cross-contamination between the groups.  
For all the intervention groups, the peer educators will be young mothers who will receive 
formal training on adolescent education and support with a focus on HIV/STIs and adolescent 
RH. The intervention messages for the one on one education and support will be similar as 
that provided to the group but they will be tailored to the adolescent’s particular situation.  
3.4.6.1 Counseling guide:   
We will adapt the Comprehensive Family Planning and Reproductive Health Training 
Curriculum for adolescents.[32] Per the copyright instructions, any part of the curriculum may 
be reproduced or adapted to meet local needs without prior permission from Pathfinder 
International provided Pathfinder International is acknowledged, and the material is made 
available free of charge or at a cost. We plan to avail any materials that we develop from this 
study free of charge to the MOH and other stakeholders while acknowledging use of materials 
from Pathfinder International.  
  
Two facilitators will pretest this curriculum with pregnant adolescent girls and they will take 
detailed notes of issues encountered during the pre-test and refine the guide accordingly and 
conduct further pretesting if needed. The guide will be adopted primarily for use to train peer 
educators with the support of trained counselors/facilitators.   
 
3.4.6.2  
Training of study staff   
MCH staff from Mulago (and, if needed, other targeted health facilities) and community support 
groups will be sensitized to the study objectives, and technical staff including peer educators, 
counselors, research assistants and study coordinators will be trained in good clinical practices 
(GCP) and human subject protection (HSP) and use of the study protocol, standard operating 
procedures (SOPs) and case record forms (CRFs). In addition to the training above, 
experienced peer educators will also be trained in depth in the use of the Comprehensive 
Family Planning and Reproductive Health Training Curriculum guide. All trained staff will be 
mentored on a regular basis by on-site investigators, counseling supervisors and the Study 
Coordinator.  
  
3.5 Study Procedures  
Information is provided below and in Appendix I on when each study procedure is to be 
performed.   
Pre-screening:  
Study staff may pre-screen potential study participants from the ANC clinic. During these 
interactions they may explain the study to potential participants and ascertain elements of 
presumptive eligibility, to be confirmed during screening. These include age of the potentially 

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eligible participant and her estimated gestational age and lack of diagnosed pregnancy 
complications. Potentially eligible participants will then be referred to the counselors who will 
conduct the screening and enrolment procedures, on the same day as the prescreening or a 
different day depending on how many participants are available on a particular day.  
Screening/Enrollment Visit  
During the screening and enrolment visit, the participant will provide written consent prior to 
conducting any screening procedures. Screening for the study involves administering the 
study eligibility criteria and for participants who do not meet eligibility criteria, screening will be 
discontinued once ineligibility is determined. Consenting eligible participants will be enrolled 
and randomized into one of the three arms. The procedures done at the screening and 
enrolment visit are outlined in the table below.   
  
Table2: Screening/Enrolment Visit  
Component  
Procedure/Analysis  
  
Administrative: Screening  
• 
Eligibility Determination  
• 
Obtain written Informed Consent for Screening and Enrolment.  
Administrative: Enrollment  
• 
Assign Participant ID   
• 
Randomization  
• 
Update Locator Information   
• 
Collect Demographics   
• 
Schedule Next Visit   
• 
Reimbursement  
Behavioral  
• 
Baseline Behavioral Questionnaire and ACASI   
• 
HIV pre and posttest counseling  
• 
Demonstration and Provision of Condoms  
Clinical  
• 
Collect baseline RH and Medical History   
• 
Record any Clinical Events  
• 
Perform Clinical Examination (abdominal palpation)    
• 
Provide available test results  
• 
Provide treatment/referral as appropriate  
  
  
  
  
Laboratory  
Blood  
  
  
  
  Collect Blood  
 
2mls for HIV-1  Serology (rapid tests)  
 
2mls for Syphilis serology RPR (TPAB if positive)  
Urine  
  Collect Urine (20mls)  
 
Rapid test for Gonorrhea infection  
 
Rapid test for Chlamydia infection  
  
Pelvic  
• 
Collect vaginal swab for rapid Trichomonas vaginalis testing  
• 
Collect swab for Bacterial vaginosis testing (PH, Whiff and Clue 
cells  
  

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Enhanced  
Peer  
Support 
Education  
and  
Counseling 
(Intervention)  
Depending on the group the participant is randomized to, the 
intervention will be done around 4 weeks after enrolment as this is 
logistically appropriate for the study. Participants in Arm 2 will be put 
in homogenous groups (similar gestation, age group and language 
preference) of 8 – 12 adolescents, while the Arm 3 participants will 
schedule their individual follow-up visits on the same day as their 
clinic visits.  
Participants in the Control Arm will receive routine antenatal, 
delivery and follow-up services with next study visit at 3 months 
postpartum    
Qualitative component  
Participants preselected for the serial IDIs and FGDs  will have the 
baseline interviews and FGDs within 3 weeks of enrolment prior to 
receiving the intervention  
  
The participant will be provided with an appointment card (usual cards used in the ANC/PNC 
clinics) however a round colored sticker (different colors for each study arm) will be placed on 
the card to differentiate the 3 study groups.  
  
STI treatment will be provided for any curable STI diagnosed at screening and in follow-up for 
the participant and her partner/s in accordance with national treatment algorithms.[33-34]  
Participants found to be HIV positive (by two separate  rapid tests) will not be excluded from 
this proposed study but will be counseled, encouraged to disclose to their partner/s and will 
receive PMTCT services including Option B+ with ARV treatment for life as per national 
guidelines. As part of PMTCT services they will be encouraged to invite their partner/s for HIV 
C&T and their HIV-exposed infants will be followed up with linkages to ongoing services. 
Participants with positive syphilis tests will be treated and have repeat testing done per local 
national guidelines and also at the final visit.  
3.5.1 Follow-up and Study Exit Visits   
3.5.1.1 Every month after enrolment during pregnancy through delivery and at 6, 10 
and 14 weeks and 6 and 9 months postpartum  
During follow-up the study procedures and STI screening tests will be done as summarized 
in the table below.   
  
Table 3: Week 36 Antepartum, Delivery, Week 6 and 10, Month 3, 6 and 9 Postpartum  
Component  
Procedure/Analysis  
Administrative and Regulatory 
(all visits including delivery 
contact for intervention groups)  
• 
Review/update locator information   
• 
Provide reimbursement for study visit ⃰  
• 
Schedule next visit   
  
Behavioral  
 (at 3, 6 and 9 months)  
• 
Conduct behavioral assessment   
• 
HIV pre- and post-test counseling†  
  
Clinical   
(at 36 weeks Antepartum, and 
as indicated)  
• 
Review and update RH and Medical History   
• 
Perform Clinical Examination¥  
• 
Prescribe/provide preferred contraceptive method  
• 
Provide available test results  
• 
Provide treatment/referral as appropriate  

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Laboratory  
Blood  
  
  
  
  Collect Blood  
 
2mls for HIV-1  Serology (rapid tests)†  
 
2mls for Syphilis serology RPR (TPAB if positive)  
Urine  
  Collect Urine (20mls)  
 
Rapid test for Gonorrhea infection  
 
Rapid test for Chlamydia infection  
 
Urine for Protein and glucose¥  
  
Pelvic  
• 
Collect vaginal swab for rapid Trichomonas vaginalis testing  
• 
Collect swab for Bacterial vaginosis testing (PH, Whiff and Clue 
cells0  
• 
Collect vaginal swab for testing presence of Y chromosome ‡  
Enhanced 
Peer 
Support 
Education and Counseling  
(Intervention)  
(at 6, 10 and 14 weeks ,6 and  
9 months  
Depending on the group the participant is randomized to, the 
intervention will be done ±2 weeks at all scheduled study visits. This 
is to allow flexibility in scheduling the sessions for the intervention 
groups  
  
Participants in the Control Arm will have the routine care provided to 
postpartum in the postnatal clinic  
Qualitative component  
Participants preselected for the serial IDIs and FGDs will have the 
final interviews and FGDs within 2 weeks of the scheduled final 
education and support session at study exit.  
In addition, single IDIs will be conducted for participants who  
 
seroconvert, have ≥2 STIs or have recurrent pregnancy at any time 
during follow-up.  
 .⃰ Only at 3 months and study exit (month 9 or 6 for the last participants to enroll), † Pre/posttest 
counseling and HIV testing done only at 3 months and study exit, α STI lab tests done at study 
exit and when clinically indicated,   ¥done at 36 weeks of gestation for all study groups, ‡ done 
only at study exit for participants with self-reported consistent condom use  
3.5.2 Behavioral Evaluations  
Behavioral evaluations assessed by ACASI and interviewer administered questionnaires 
include;   
• 
Frequency of unprotected sex (self-report of penetrative sexual intercourse since previous 
visit)/report of condom use  
• 
Risk behaviors – including any new sexual partners/ encounters, concurrent sexual 
partners (stable or casual), alcohol/drug use, domestic violence e.t.c.  
• 
HIV/STI risk perception and motivation to utilize RH and pregnancy related services  
• 
Reproductive intentions and family planning  
• 
Male partner/s involvement – presence, cohabitation, economic, psychosocial support, 
health care support, gender based violence etc  
3.5.3 Psychological Assessments  
The following psychological assessments will be conducted at enrolment (baseline), 3 months 
& at study exit;  
• 
Psychosocial risk assessment using the HEADDS assessment instrument  
• 
Self-esteem assessment using the Rosenburg self-esteem scale[35]   
• 
Psychological wellbeing using Ryff’s scale[36] of psychological wellbeing  

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3.5.4 Clinical Evaluations and procedures  
This involves history taking, physical and/or pelvic exams and other evaluations as indicated.  
  
History Taking  
• 
Demographic information is obtained  
• 
Risk assessment during pregnancy to rule out any maternal problems (medical and 
obstetric history and update this history as appropriate)  
• 
Postpartum, obtain history on any maternal problems (medical, gynecological (including 
symptoms of STIs) and contraceptive use history and update as appropriate  
Physical Exam:  
• 
General physical exam – signs of anemia, BP, weight, breast   
• 
Obstetric exam during pregnancy   
• 
Additional clinical assessments may be performed at the discretion of the examining 
clinician in response to symptoms or illnesses present at the time of the exam  
Other procedures which shall be done as indicated: prescribe contraceptives, provide 
available test results and provide treatment/referral as appropriate  
3.5.5 Laboratory Evaluations  
 
  Urine (25mls)  
 Urine dipstick for protein and glucose  
 HCG for pregnancy (5mls)  
 Rapid test for Gonorrhea infection (10mls)  
 Rapid test for Chlamydia infection (10mls)  Blood (4mls)  
 2mls for HIV serology (using national algorithm) [37]   
 Hemoglobin Concentration (Hb) by Hemocue ®   
 2mls for RPR for syphilis (TPAB if positive)  
Throughout the study duration, the total amount of blood collected from each participant 
will be about 10mls.  Pelvic  
 Rapid test for Trichomonas   
  
 Bacterial Vaginosis Testing – PH, Clue Cells, whiff test and homogenous abnormal 
vaginal discharge.  
Bacterial vaginosis will be diagnosed using the following Amsel criteria. The presence 
of three of the following four criteria provides sufficient evidence for a clinical diagnosis 
of BV.  
a) Vaginal pH >4.5 ((normal range 3.8 to 4.5)  
b) The presence of clue cells (bacterial clumping upon the borders of epithelial 
cells) on wet mount examination. Clue cells should constitute at least 20% of 
all epithelial cells (an occasional clue cell does not fulfill this criteria).  
c) Positive amine, "whiff" or "fishy odor" test (liberation of biologic amines with or 
without the addition of 10% Potassium Hydroxide (KOH)).  
d) Homogeneous, nonviscous, milky-white discharge adherent to the vaginal walls   
  
 Vaginal fluid for testing presence of Y chromosomes sequences. This is to validate 
women sexual behavior reporting whether there was unprotected sex in last 14 days.   

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3.5.6 Retention  
Once a participant is enrolled and randomized into the study, the study staff must make every 
effort to retain her in follow-up to minimize possible bias associated with loss-to-followup. 
Standard operating procedures (SOPs) for participant retention to target loss-to-follow-up 
rates less than 10% shall be developed. As such, the average retention rate of 95% will be 
targeted for this study. All study staff are responsible for implementing local SOPs to achieve 
this. Components of such procedures may include the following:   
• 
Thorough explanation of the study visit schedule and procedural requirements during 
the informed consent process and re-emphasis at each study visit. Also as part of the 
informed consent process, encouragement of participants to discuss potential study 
participation with their husbands/partners and other influential family members or 
persons.   
• 
Thorough explanation of the importance of all study groups to the overall success of 
the study.   
• 
Collection of detailed locator information at the study screening and enrolment visits, 
and active review and updating of this information at each subsequent visit.   
• 
Use of mapping techniques to establish the location of participant residences and other 
locator venues.   
• 
Ensuring ongoing contact with the study participant including soon after delivery and 
reminders about scheduled study visits  
3.6 Study Endpoints   
3.6.1 Quantitative data outcomes  
Primary outcomes   
1. Incidence of one or more STIs during study follow-up, with STIs confirmed by laboratory 
tests of HIV-1, Neisseria Gonorrhea, Treponema pallidum (Syphilis), Chlamydia 
trachomatis, Bacterial Vaginosis or Trichomonas vaginalis (Composite outcome)  
- 
New HIV-1 diagnosis by 2 separate HIV tests with negative HIV-1 test at enrollment 
AND/OR     
- 
New Neisseria Gonorrhea, Treponema pallidum (Syphilis), Chlamydia trachomatis, 
Bacterial Vaginosis or Trichomonas vaginalis test having been negative at enrollment 
OR with completed treatment if positive at baseline      
2. Reported (and validated) consistent condom use and uptake of effective contraceptive 
method (Composite outcome)  
- 
Absence of repeat pregnancy (diagnosed by rapid urine pregnancy testing for HCG)   
- 
Uptake of effective contraceptive method with insertion/prescription by clinic staff from 
3 months postpartum to 9 months or study completion (which ever comes 1st)   
- 
Self-reported consistent use of condoms during penetrative anal or vaginal sex 
including a) since enrollment b) since last visit c) at last penetrative sex act   
- 
Absence of Y-chromosome in analysis of vaginal swabs        
Secondary outcomes   
3. Acceptability/desirability of assigned clinic service model    
Acceptability of clinic service model (composite)   
- 
Frequency of visits  
- 
Relevance of information to own life   
- 
Sense of psychosocial support     

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3.6.2 Qualitative data outcomes  
Data collected from focus group discussions and key informant interviews will be triangulated 
with quantitative data to address:  
(1) Adolescents’ knowledge, Attitudes and Practices towards RH and pregnancy related 
services  
(2) Health care providers’ attitude towards adolescent RH services, perception of 
adolescents’ attitudes towards pregnancy, RH services and challenges for 
adolescents follow up in the current ANC and post-delivery care  
(3) Effect of adolescents’ HIV/STI risk perception and motivation to utilize services 
including condom use  
3.7 Statistical considerations and analysis plan   
3.7.1 Sample size determination  
Sample size determination  
Sample size for this study was based on the outcomes, uptake of effective contraceptive, or 
prevalence of STIs, at last follow-up comparing each of the two interventions to the control in 
this three-arm trial. We assumed the uptake of effective contraceptives and consistent condom 
use as a composite outcome to be 10% [38] (in control/standard), 30% and 35% at the last 
follow-up in the two intervention arms. At 80% power, and 5% type 1 error rate, and a 10% 
loss to follow-up, the sample size in the intervention arms was 100 (each 50), while the 
control/standard was adjusted to 71; this follows a recommendation by Fleiss et al for multiple-
arm trials that control arms have a bigger sample size than the intervention.   
  
For the prevalence of STIs, we assumed 20%[10] in control/standard arm, 10% in the 
intervention-1, and 8% in intervention-2 at the last follow-up, suggesting an average of 55% 
reduction in prevalence of STI. With similar power of 80%, 5% type-1 error rate and 10% loss 
to follow-up, a total of 215 respondents in control/standard arm, and 152 per each of the 
intervention arms resulting in a total of 519. Since 519 respondents are sufficient to address 
the objectives of the uptake of effective contraceptives + consistent condom use, we 
determined that the final sample size for this study will be 519 (215 control/standard arm; 152 
per each of the two intervention arms).  
   
  
3.7.2  Statistical analysis   
Exploratory data analysis will be conducted on all variables including the binary outcomes. 
Descriptive statistics will be generated providing proportions (percentages) for categorical 
data, and mean (SD)-for normally distributed data, and median (IQR) nonnormal continuous 
variables. A consort diagram will also be generated to show the time of enrollment, and follow-
up. Bar charts showing the distribution of categorical data will also be generated. Data will be 
assessed for missingness especially as a result of non-follow-up in this prospective study 
design. In order to address this concern, a comparison of non-follow-up and those followed up 
will be done, and propensity scores will be constructed to use as weights in the regression 
models. For categorical/dichotomous outcomes, we will use Fishers Exact Test or chi-square 
as appropriate, and will report the respective 95% confidence intervals around point estimates, 
which offer important interpretation for the trial findings.  
  
Primary outcome-1: Composite measure of consistent condom-use and use of an effective 
FP method. A comparison of this binary outcome will be conducted at the last follow-up. A log-

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binomial regression model will be used to obtain the prevalence rate ratios (PRR) as the 
measure of effect or association, because the outcomes are greater than 10%.  The primary 
exposure variable is study arm. The two intervention arms will be compared to the control arm 
in the same model. Potential confounders will be adjusted for, after assessing for interaction 
of some variables with the study-arm in the association with the primary composite outcome. 
Respondents from the same facility may be correlated, and so adjustment for potential 
clustering of observations within the selected facilities will be done.  
  
Primary outcome-2: Incidence of any STI.  Kaplan-Meier survival analysis will be conducted 
to determine differences in the probability of STI infection between study arms. Differences in 
the KM will be determined by log-rank test.  Further analysis will be conducted using Poisson 
regression models to obtain incidence rate ratios (IRR) comparing the two intervention arms 
to the control arm in the same model. Potential confounders will be adjusted for, after 
assessing for interaction of some variables with the study-arms in the association with the 
incidence of STI. Adjustment for potential clustering of observations within the selected 
facilities will be done.  
  
Potential confounders to be adjusted for in these analyses will include participant 
characteristics such as age, education level. The primary analyses are the intention to treat; 
for descriptive analysis, baseline data will be summarized separately by study arm.  All the 
analysis will use STATA version 12  
3.7.3 Qualitative data analysis   
Data Sources  
The qualitative data from this study will include the following data sources:   
a) Handwritten notes and summaries of IDIs and KIIs   
b) IDI and KII debriefing reports  
c) Transcripts from audio-recorded KIIs, IDIs and FGDs.   
d) Summaries from the psychological assessments  
Analysis Overview   
The primary source of qualitative data used in the analysis will consist of raw textual data. 
Qualitative data will be audio-recorded, transcribed, translated into English and coded for 
qualitative analyses, using NVivo or a similar qualitative software. Data coding will be used as 
a primary analytical approach, for data reduction, that is, to summarize, extract meaning, and 
condense the data. The transcripts will be coded first through descriptive coding for key 
themes and topics, using a preliminary codebook.  Additional codes will be identified through 
an iterative process of reading the textual data to identify emergent themes, and the codebook 
will be modified accordingly. In addition to descriptive codes, pattern codes, which achieve a 
greater level of abstraction, will be used to start linking themes and topics together.  The 
analysis will be done by the investigative team, working interactively through regular face-to-
face meetings, emails, and regular phone calls. The findings and interpretations of the data 
will be critically discussed until there is group consensus on the dominant themes and 
meanings contained in the data.  
  
The primary final output of the qualitative analysis will include a synthesized report with 
representational quotes that will describe the health care provider and adolescent mothers’ 
Knowledge Attitude and Practice (KAP) regarding adolescent reproductive health and 
pregnancy related services with pregnant and postnatal adolescent mothers and postdelivery 
care.  

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3.8 Data quality and management   
SOPs will be developed for all data management process and procedures to ensure 
consistency and quality of data.   
  
Quantitative data will be collected and entered by research staff on CRFs and Android 
electronic tablets (hand-held computers) using a computer-assisted personal interviewing 
(CAPI) software for the ACASI.  
Qualitative data will be collected manually and on a voice recorder and will be transcribed 
into laptop computers by research assistants for subsequent coding in NVivo software and 
analysis. All discussions will be conducted in the local languages, will last no more than 90 
minutes, and will be digitally recorded and transcribed into English. Interviewers/research 
assistants will have experience in qualitative methods including in-depth interviewing and 
probing where appropriate and relevant. Digital recordings will be transferred to secure 
computers and deleted from source computers.   
  
All data clerks and managers will have received training on the requirements of strict 
confidentiality regarding patient identifying information, and laptop security. To protect detailed 
health and personal information data, study record keeping and access to participant 
identifying information will follow strict written SOPs and data will be subjected to a variety of 
quality control procedures. All records will be kept on password protected computers at MU-
JHU. Participants will be identified primarily by their study number. All CRFs and identifiers will 
be kept in individual files in secured, access-limited room at the site. No individual participant 
identifier will be used in any reports or publications resulting from the study. Study investigators 
and coordinators will continuously mentor and monitor staff to ensure these procedures are 
followed according to SOPs in order to ensure data quality and confidentiality.  
  
  
  
  
  
  
  
  
  
  
  
4 ANTICIPATED CHALLENGES AND MITIGATION PLANS  
4.1 Maintaining Long –Term cohesion among peers   
This will depend on the individual stability of the members, the group leader capability, and the 
quality of their relationships. This will require close monitoring and support by the group 
leaders and peer educators. We will ensure that there is continuous training, counseling and 
ongoing support sessions to address issues as they arise and support long-term cohesion 
including an understanding and commitment of protecting each other’s privacy and not sharing 
confidential disclosures outside the group.   
4.2 Stigma and discrimination:      
HIV-related stigma and discrimination continue to be important issues in Uganda. MUJHU may 
be perceived as being associated with HIV research; so participants attending MUJHU may 
be suspected by others of being HIV-infected (despite many HIV-uninfected persons attending 
MUJHU). MUJHU will consult with youth and attempt to mitigate against this risk by rebranding 
and marking the lower building ground floor which has a separate entrance and exit as a 

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Youth-Friendly Service. Clinic services for teens will be on the ground floor and separated 
from other clinic and study populations.      
   
4.3 Vulnerability of pregnant and postpartum women to relocate:   
The time immediately after delivery may be associated with geographic displacement as many 
new mothers move for several weeks or months to their village of origin after delivery both 
because of the care needed by the new infant (and mother) and Uganda cultural norms among 
several tribes. We will attempt to minimize this through exploring this theme in our FGDs as 
well as our screening and enrollment procedures inquiring about intentions to remain within 
30Kms of the clinic and encouraging women to advise of any temporary or permanent change 
in residence and maintain contact with the study team. We will also maintain regular contact 
with participants through their scheduled visits and by phone calls/sms using agreed general 
language with no mention of HIV or MUJHU).      
4.4 Male partner and family involvement:   
Male partner involvement continues to be a challenge in many parts of the country due to 
cultural, historical and structural factors. Among pregnant and postpartum adolescents there 
is a higher proportion without the ongoing support of male partners and a higher proportion 
dependent on their parents compared to adult women. In this intervention we will continuously 
encourage the participant to bring their partner/s to the education sessions on case by case 
basis and we will also encourage partner C&T.   
4.5 Depression and psychological distress:   
Pregnant adolescents and young mothers may be at a greater risk for anxiety and depression 
(including postpartum depression) and have a relatively low rate of health seeking behavior 
for their own health and that of their infants. While it is unlikely that the study itself would be 
causal (and would be more likely to assist young persons) the study evaluations are likely to 
identify any significant psychological distress or psychiatric disorder which would allow for 
early and appropriate referrals to an appropriate health provider (such as the Mulago Specialist 
Adolescent Clinic).        
  
  
5 HUMAN SUBJECTS PROTECTIONS   
5.1     Institutional Review Boards/Ethics Committees  
This protocol and the associated consent documents and study-related documents (such as 
participation education and recruitment materials) will be reviewed by the primary IRB in 
Uganda and other regulatory bodies responsible for oversight of NIH sponsored research 
conducted in Uganda as well as regulatory bodies required by the sponsor. Any amendments 
to the protocol will be approved by the IRBs prior to implementation. Subsequent to the initial 
review and approval, the responsible IRBs will review the study at least annually in accordance 
with national requirements. Investigators will make safety and progress reports to the IRBs at 
least annually and within three months after study termination or completion. These reports 
will include the total number of participants enrolled in the study, the number of participants 
who completed the study, all changes in the research activity, and all unanticipated problems 
involving risks to human subjects or others.  
  

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5.2     Risk Benefit Statement  
5.2.1  Risks   
This study involves the vulnerable population of pregnant adolescents. Pregnant adolescents 
under the age of 18 are by definition considered emancipated minors.   
  
The provision of routine clinical antenatal, delivery and postnatal services are not part of this 
study. Additional study related procedures do include provision of specific clinical services 
such as HIV and STI tests (requiring blood draws, vaginal swabs and urine specimens) as well 
as clinical examination and counseling and provision of contraception.   
The main risks would be potential loss of privacy. The investigators will make all possible 
efforts to minimize risks to these adolescent study participants and to ensure confidentiality of 
the study participants and their study data. All staff will be trained on Human Subjects 
Protection and Good Clinical Practice.  Before beginning the study, the investigators will have 
obtained approval from all relevant IRBs and from the Uganda National Council for Science 
and Technology (UNCST). The investigators will permit monitoring by relevant regulatory 
authorities, the NIH, applicable US/local government bodies, IRBs and UNCST, or their 
appointed agents. Subsequent to the initial review and approval, the responsible IRBs will 
review the study at least annually. Investigators will make safety and progress reports to the 
IRBs at least annually and within three months after study termination or completion. Adverse 
events will be reported according to local regulatory and NIH guidelines.   
  
Since participation in the proposed clinical research includes the risks of loss of confidentiality 
and discomfort with the personal nature of certain questions asked as part of the study, every 
effort will be made to protect participant privacy and confidentiality. All participant information 
will be stored in locked file cabinets in secure areas with access limited to authorized study 
staff. Individual participants’ study information will not be released without their written 
permission, except as necessary for regulatory monitoring, and/or auditing.   
5.2.2 Benefits  
Participants may benefit directly from the individual or group educational and supportive 
counseling provided, treatment for HIV and other STIs for themselves and/or their 
husband/partner/s and from counseling and provision and uptake of dual protection methods 
with effective contraception and barrier protection. Participants and others may benefit in the 
future from information learned from this study. Specifically, information learned in this study 
may help improve interventions which provide psychosocial support and education and 
prevent STIs/HIV and unwanted pregnancies among adolescent girls.  
  
5.3  Informed Consent Process  
Written informed consent will be obtained from all potential study participants including those 
emancipated minors aged 15 to 17 years following the National Guidelines for Research 
involving Humans as Research Participants issued by UNCST [31]. Parents or guardians need 
not be involved in the informed consent process since these adolescents are emancipated 
minors. However should the adolescents less than 18 years of age wish to include one or both 
parents (or their spouse/partner) in the informed consent process they will be free to do so.   
  
Study staff will administer a comprehension checklist to potential participants prior to obtaining 
written informed consent to ensure that participants fully comprehend the nature of the study. 
In obtaining and documenting informed consent, the investigators and their designees will 
comply with applicable local and domestic regulatory requirements and will adhere to Good 

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Clinical Practices (GCP) and to the ethical principles that have their origin in the Declaration 
of Helsinki. Participants are always offered a copy of their informed consent form. The consent 
forms will clearly indicate the purpose of the study, the procedures to be followed, and the 
potential risks and benefits of participation, in accordance with all applicable regulations.  
.   
5.4 Participant Confidentiality  
All study procedures will be conducted in private, and every effort will be made to protect 
participant privacy and confidentiality of client information. The study staff will implement 
confidentiality protections and the input of study staff and community representatives to 
identify potential privacy and confidentiality issues and strategies to address them. All 
studyrelated information will be stored securely at the study site. All participant information will 
be stored in locked file cabinets in areas with access limited to study staff. Participants’ study 
information will not be released without their written permission, except as necessary for 
review, monitoring, and/or auditing IRB, regulatory bodies or sponsor.  
5.5    Special Populations  
This section outlines considerations made for the inclusion or exclusion of special populations 
in this study.   
  
As pregnant adolescents have a high burden of disease and social exclusion/stigma and this 
study is purposely designed to assess acceptability and effectiveness of strategies to address 
these issues it is critical that pregnant adolescents is included as the study population. The 
risks associated with participating in the study are minimized and mitigated by the study 
design. As such they meet the ethical criteria of being both at risk and standing to benefit from 
the proposed interventions.   
  
We have determined however that pregnant adolescents with significant comorbidity or fetal 
loss should be excluded from the study as they would be likely not to be able to comply with 
the study requirements (of visit attendance) and/or would require additional specialized 
counseling and other support over that available within the study.       
5.5.1   Pregnant Women  
Pregnant women will be offered enrollment in this study in accordance with guidelines set forth 
in the Ugandan ethics guidelines [31] and current US guidelines.[39] Given that the primary 
purpose of the research is to meet the health needs of the mother informed consent will not 
be sought from the father of the baby.  However should the pregnant women wish to include 
her spouse in the informed consent process they will be free to do so.     
5.5.2 Children   
This study plans to include emancipated minors as study participants; that is pregnant children 
who are aged 15 to 17 years at the time of enrollment.[31] Informed consent procedures follow 
Uganda ethical requirements for emancipated minors.    
5.6 Compensation  
Compensation for participants’ time and travel will be provided to participants at a rate of 10, 
000 Uganda shillings per scheduled study visit.   
  
Of note if FGD and IDIs are scheduled on a separate day to other study visits these would be 
considered as a scheduled study visit. If scheduled on the same day as a scheduled study 
visit an additional 5,000 Uganda shillings would be paid to compensate participants for the 
additional time involved.     

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If a study participant moved more than 30kms away (despite indicating they would stay within 
30kms in the enrollment interview) or experienced transport costs greater than 10,000 
Ugandan shillings, the study team would reserve the right to consider this on a case by case 
basis with the possibility of reimbursing actual transport costs.   
  
5.7   Access to HIV-related Care (HIV Counseling and Testing and 
HIV care)  
HIV testing for participants will be offered together with pre-test and post-test counseling by 
trained study counselors. Referral for additional counseling will occur if identified as a need by 
the counselor or the participant. Participants diagnosed as HIV-positive will receive 
appropriate referrals to nearby adolescent HIV care and treatment services at the Baylor 
Adolescent Clinic (Centre of Excellence) for ongoing management. Sexual partner/s of teen 
participants with positive HIV or other STI tests will be invited to attend the clinic and receive 
counseling, testing, treatment (if applicable) for other STIs and referred for appropriate 
services. HIV exposed infants will also be followed up appropriately in the PMTCT program 
the mother is referred to.   
  
5.8 Study Discontinuation  
This study may be discontinued at any time by NIAID, the OHRP, other governmental or 
regulatory authorities, or site IRBs/ECs  
  
  
  
  
  
  
  
  
6 PUBLICATIONS AND DISSEMINATION OF STUDY FINDINGS    
6.1 Dissemination of findings:  
Research findings will be shared with all the stakeholders including study participants, CAB 
members, participating health facilities’ staff, Ministry of Health, the Ugandan Society for 
Adolescent Health, PEPFAR and donor representatives and other policymakers. The 
implementation science findings will also be submitted for presentation at regional and 
international meetings and for publication/s in the peer-reviewed scientific literature.   
6.2 Sustainability:   
Both the Ministry of Health Reproductive Health staff and the Makerere University Department 
of Obstetrics/Gynecology are highly supportive of this project as noted in their letters of 
support.  If either or both of the enhanced adolescent group or individualized peer support 
interventions show acceptability, feasibility coupled with significantly improved uptake of 
effective contraceptives and barrier protection and reduced incidence of HIV/STIs when 
compared to the routine care control group, the investigators will work with MOH, PEPFAR 
and other donors to mobilize resources and implement these adolescent reproductive  
services in other parts of Kampala and other health districts across Uganda.   
  

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7 TIMELINE   
  
This administrative supplement proposal will be conducted over a 12 month period from the 
point of IRB approval. The proposed activities and timeframes are summarized in the GANNT 
chart below.   
  
Schedule for implementation of study activities  
   
Year 1    
 
 
 
 
 
 
 
 
Activities  
1  2  3  4  5  6  7  8  9  10  11  12  
Hiring staff  
    
                        
   
   
FGDs of formative research  
 
 
 
 
 
 
 
 
 
 
 
Training of staff  
                              
   
   
Pretesting  
of  
Intervention  
 
 
 
 
 
 
 
 
 
 
 
curriculum  
 
 
 
 
 
 
 
 
 
 
 
 
Site Activation  
                              
   
   
Enroll participants  
                              
   
   
Follow up of participants  
                              
   
   
Study Annual Renewal IRBs  
                              
   
   
Data Analysis and Manuscript 
writing  
                              
   
   
Dissemination of findings  
                              
   
   
  
   
  
  
REFERENCES   
  
1. 
Atuyambe, L., et al., Experiences of pregnant adolescents-voices from Wakiso district, 
Uganda. African health sciences, 2007. 5(4): p. 304-309.  
2. 
Atuyambe, L., et al., Seeking safety and empathy: adolescent health seeking behavior 
during pregnancy and early motherhood in central Uganda. Journal of adolescence, 
2009. 32(4): p. 781-796.  
3     http://www.unicef.org/uganda/UNICEF_UGANDA_FAST_FACTS_July_2012.pdf.  
4. 
Nalwadda, G., et al., Persistent high fertility in Uganda: young people recount 
obstacles and enabling factors to use of contraceptives. BMC Public Health, 2010. 
10(1): p. 530.  
5. 
Uganda Bureau of Statistics (UBOS) and ICF International Inc. 2012. Uganda 
Demographic and Health Survey 2011 K, U.U.a.C., Maryland: ICF International Inc.  
6. 
Uganda AIDS Indicator Survey. Report.  2011  [cited 2014 08 December]; Available 
from: http://health.go.ug/docs/UAIS_2011_Report.pdf.  
7. 
Neema, S., et al., Adolescent sexual and reproductive health in Uganda: results from 
the 2004 National Survey of Adolescents. Occasional Report, 2006. 25.  

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8. 
Muhumuza, R. Associated Press World AIDS Day: As HIV rises, activist targets youths.  
2014; Available from:  
http://www.freep.com/story/news/world/2014/12/01/world-aids-day-hiv-rises-
activistreaches-youths/19730505/.  
10. 
Råssjö, E.-B., et al., Prevalence of sexually transmitted infections among adolescents 
in Kampala, Uganda, and theoretical models for improving syndromic management. 
Journal of adolescent health, 2006. 38(3): p. 213-221.  
11. 
; Available from: http://en.wikipedia.org/wiki/Peer support?oldid=632669948.  
12. 
Mead, S., D. Hilton, and L. Curtis, Peer support: a theoretical perspective. Psychiatric 
rehabilitation journal, 2001. 25(2): p. 134.  
13. 
Salzer, M.S., Consumer-Delivered Services as a Best Practice in Mental Health Care 
Delivery and The Development of Practice Guidelines: Mental Health Association of  
Southeastern Pennsylvania Best Practices Team Philadelphia. Psychiatric  
Rehabilitation Skills, 2002. 6(3): p. 355-382.  
14. 
Mead, S. and C. MacNeil, Peer support: What makes it unique. International Journal 
of Psychosocial Rehabilitation, 2006. 10(2): p. 29-37.  
15. 
Sarason, I.G., et al., Assessing social support: the social support questionnaire. 
Journal of personality and social psychology, 1983. 44(1): p. 127.  
16. 
Flannery Jr, R.B., Social support and psychological trauma: A methodological review. 
Journal of traumatic stress, 1990. 3(4): p. 593-611.  
17. 
Young, K.W., Social support and life satisfaction. International Journal of 
Psychosocial Rehabilitation, 2006. 10(2): p. 155-164.  
18. 
Thoits, P.A., Social support as coping assistance. Journal of consulting and clinical 
psychology, 1986. 54(4): p. 416.  
19. 
Solomon, P., Peer support/peer provided services underlying processes, benefits, 
and critical ingredients. Psychiatric rehabilitation journal, 2004. 27(4): p. 392.  
20. 
Schubert, M.A. and T. Borkman, 13. Identifying the Experiential Knowledge 
Developed Within a Self-Help Group. Understanding the self-help organization: 
Frameworks and findings, 1994: p. 227.  
21. 
Coyne, J.C. and A. DeLongis, Going beyond social support: the role of social 
relationships in adaptation. Journal of consulting and clinical psychology, 1986. 54(4): 
p. 454.  
22. 
Salzer, M.S. and S.L. Shear, Identifying consumer-provider benefits in evaluations of 
consumer-delivered services. Psychiatric rehabilitation journal, 2002. 25(3): p. 281.  
23. 
Festinger, L., A theory of social comparison processes. Human relations, 1954. 7(2): 
p. 117-140.  
24. 
Riessman, F., The" helper" therapy principle. Social Work, 1965.  
25. 
Skovholt, T.M., The client as helper: A means to promote psychological growth. The 
counseling psychologist, 1974.  
26. 
UNAIDS, Peer education and HIV/AIDS concepts, uses and challenges. 1999, 
UNAIDS: Geneva.  
27. 
Shoemaker, K., Educating with peers - others do- should you? 1998, George town 
University.  
28. 
UNAIDS, PEER EDUCATION AND HIV/AIDS:  Concepts, uses and challenges. 
Geneva, Switzerland. 1999.  
29. 
Musingye, E., et al., Integration of peers in the PMTCT and postnatal clinics (PNC), 
increased subsequent family planning refill visits by HIV-infected women in an urban 
hospital in Kampala., in Conference on HIV Pathogenesis and treatment. 2012.  
30. 
Lynn Atuyambe, P., et al., Coping Responses During Pregnancy and Early 
Motherhood  
             Among Adolescents in Central Uganda. 2008. 13: p. 18.  

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31. 
Uganda National Council for Science and Technology (UNCST). 2014. National 
Guidelines for Research involving Humans as Research Participants. Kampala, U.  
32. 
PATHFINDER.  
Module-16-Reproductive-Health-Services-For-Adolescents-
Training Guide.    
2004;  Available  
from: 
 
http://www.pathfinder.org/publicationstools/pdfs/Module-16-Reproductive-Health-
Services-for-Adolescents-TrainingGuide_pdf.pdf.  
33. 
UMDPC. 
Uganda-Clinical-Guidelines. 
 
2012; 
Available 
from: 
umdpc.com/wpcontent/.../2014/02/Uganda-Clinical-Guidelines-2012.pdf.  
34. 
WHO, Guidelines for the Management of Sexually Transmitted Infections. 2003.  
35. 
Rosenberg, M., Society and adolescent self image. Princeton ,NJ. Princeton 
University Press, 1965.  
36. 
Ryff, C. and C. Keyes, The structure of psychological wellbeing revisited. Journal of 
personality and Social psychology, 1995. 69: p. 718-727.  
37. 
MOH. Uganda National Policy Guidelines for HIV Counselling and Testing.  2005; 
Available from: http://www.who.int/hiv/pub/guidelines/uganda_art.pdf.  
38. 
Wanyenze, Rhoda K., Nazarius M. Tumwesigye, Rosemary Kindyomunda, Jolly 
Beyeza-Kashesya, Lynn Atuyambe, Apolo Kansiime, Stella Neema, Francis Ssali, 
Zainab Akol, and Florence Mirembe. "Uptake of family planning methods and 
unplanned pregnancies among HIV-infected individuals: a cross-sectional survey 
among clients at HIV clinics in Uganda." Journal of the International AIDS Society 14, 
no. 1 (2011): 35.  
39. 
NIH. Regulations, Policies & Guidance; Ethical Guidelines & Regulations. Available 
from: http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm.  
40. 
Conner, M. and P. Norman, The role of social cognition in health behaviours. 1996.  
  
  
  
  
  
  
  
  
  
  
  
  
  
APPENDIX A: ADDITIONAL BACKGROUND ON THE CONCEPT AND USE OF THE HEALTH BELIEF  
MODEL     
   
Table from “Theory at a Glance: A Guide for Health Promotion Practice" (1997)  
Concept  
 Definition  
 Application  
Perceived  
Susceptibility  
One's 
opinion 
of 
chances of getting a 
condition  
Define population(s) at risk, risk 
levels; personalize risk based on 
a person's features or behavior; 
heighten perceived susceptibility 
if too low.  

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Perceived Severity  
One's opinion of how 
serious a condition and 
its consequences are  
Specify consequences of the risk 
and the condition  
Perceived Benefits  
One's 
belief 
in 
the 
efficacy of the advised 
action to reduce risk or 
seriousness of impact  
Define action to take; how, 
where, when; clarify the positive 
effects to be expected.  
Perceived Barriers  
One's opinion of the 
tangible 
and 
psychological costs of 
the advised action  
Identify and 
reduce barriers 
through reassurance, incentives, 
assistance.  
Cues to Action  
Strategies to activate 
"readiness"  
Provide 
how-to 
information, 
promote awareness, reminders.  
Self-Efficacy  
Confidence  
in  
one's 
ability to take action  
Provide training, guidance in 
performing action.  
  
Conceptual Model  
  
  
Source: Glanz et al, 2002, p. 52  
  
Scope and Application  
The Health Belief Model has been applied to a broad range of health behaviors and subject 
populations. Three broad areas can be identified (Conner & Norman, 1996):[40]   
1) Preventive health behaviors, which include health-promoting (e.g. diet, exercise) and 
health-risk (e.g. smoking) behaviors as well as vaccination and contraceptive practices.  2) 

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Sick role behaviors, which refer to compliance with recommended medical regimens, usually 
following professional diagnosis of illness.   
3) Clinic use, which includes physician visits for a variety of reasons.  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
APPENDIX B: SCHEDULE OF STUDY VISITS AND EVALUATIONS    
  
  
  
  
SCR/  
 ENR  
36 
weeks 
APT  
Birth 
†  
  
6  
weeks  
PPT  
  
10 
weeks 
PPT  
3  
months 
PPT  
6  
months 
PPT  
9  
months 
PPT  
ADMINSTRATIVE AND REGULATORY  
 
 
 
 
 
 
 

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Obtain Informed Consent  
X  
  
  
  
  
  
  
  
Assign  
a  
unique  
Participant  
Identification (PTID) number  
X  
  
  
  
  
  
  
  
Asses and/or confirm eligibility  
X  
  
  
  
  
  
  
  
Collect/review  
/update  locator 
information  
X  
X  
X  
X  
X  
X  
X  
X  
Randomization  
X  
  
  
  
  
  
  
  
Provide reimbursement   
X  
  
  
X  
X  
X  
X  
X  
Schedule next visit  
X  
X  
  
X  
X  
X  
X  
X  
INTERVENTION  
  
  
  
  
  
  
  
  
Enhanced  
Counseling  
Education  
Sessions/Routine care as provided  
X  
  
  
X  
X  
X  
X  
X  
BEHAVIORAL  
 
 
 
 
 
 
 
Behavioral  Assessments using IAQ and 
ACASI  
X  
  
  
  
X  
  
X  
X  
Psychosocial Assessment  
X  
  
  
  
  
  
  
X  
HIV pre and post test counseling  
X  
  
  
  
  
X  
  
X  
Provision of Condoms  
X  
X  
X  
X  
X  
X  
X  
X  
Conduct Social harms assessment  
  
  
  
  
X  
  
X  
X  
CLINICAL  
 
 
 
 
 
 
 
Obtain/review and update RH and  
Medical History   
X  
X  
*  
*  
*  
*  
*  
X  
Clinical Examination – Blood Pressure, 
Weight, Obstetric exam  
X  
X  
  
  
  
  
  
  
Prescribe contraceptives  
  
  
  
X  
*  
*  
*  
*  
Provide available test results  
X  
X  
  
*  
*  
X  
*  
X  
Provide  treatment/referral  as 
appropriate  
*  
*  
  
*  
*  
*  
*  
*  
LABORATORY  
 
 
 
 
 
 
 
  
Blood  
HIV-1  
  
Serology  
(rapid tests)  
X  
  
  
  
  
X  
  
X  
Syphilis  
serology  X  
  
  
  
  
  
€  
X  
 
RPR  
(TPAB  
if  
positive)  
 
 
 
 
 
 
 
 
  
  
Urine  
Protein and Glucose  
X  
X  
  
  
  
  
  
  
Rapid  
test  
for  
Gonorrhea infection  
X  
*  
  
*  
*  
*  
*  
X  
Rapid  
test  
for  
Chlamydia infection  
X  
*  
  
*  
*  
*  
*  
X  
HCG test  
  
  
  
*  
*  
*  
*  
X  
  
Pelvic  
Rapid  
test  
for  
Trichomoniasis 
(self 
collected 
vaginal 
swab)  
X  
*  
  
*  
*  
*  
*  
X  
Collect Vaginal swab 
for Bacterial  
Vaginosis testing  
x  
*  
  
*  
*  
*  
*  
X  

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Collect vaginal swab 
for testing presence of 
Y chromosome ‡  
  
  
  
  
  
  
  
X  
QUALITATIVE COMPONENT  
Serial In-depth Interview (SIDI)  
X  
  
  
  
X  
  
  
X  
Focus Group Discussion (FGD)  
X  
  
  
  
  
  
  
X  
Single In-depth Interview (IDI)  
  
  
  
*  
*  
*  
*  
*  
X mandatory, *If indicated †only for intervention groups, € repeat at 6months if positive at enrolment, ‡done only 
at study exit for participants with self reported condom use.